[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,378,0,25,[9,41,87,123,149,173,200,230,260,286,314,345,380,400,433,458,485,512,537,560,589,612,633,660,710],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641343","phase-2-gi-05-the-impact-of-olanzapine-among-patients-receiving-neoadjuvant-chemotherapy-for-gastric-cancer-100641343",false,"NCT07581405","GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* Histologically confirmed gastric adenocarcinoma, documented by biopsy.\n* Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.\n* Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by the study PI","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.",[26,27],"Gastric Adenocarcinoma","Gastric Cancer","NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":20},"2026-09",{"date":36,"type":20},"2030-09",{"name":38,"class":39},"University of Illinois at Chicago","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":66,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":49,"type":20},740,[23],"This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[53,54,55,27,56,57,58,59,60,61,62,63,64,65],"Advanced Solid Tumor","Melanoma","Head and Neck Cancer","Ovarian Carcinoma","Cervical Cancer","Endometrial Cancer","Bladder Cancer","Esophageal Cancer","Pancreatic Carcinoma","Prostate Cancer","Non-small Cell Lung Cancer (NSCLC)","Lung Cancer","Breast Cancer",[53,54,55,27,67,68,69,70,71,72,73,74,75,76,64,65],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402","RECRUITING",{"date":31,"type":32},{"date":80,"type":32},"2024-02-26",{"date":82,"type":20},"2028-10-10",{"name":84,"class":85},"Daiichi Sankyo","INDUSTRY",86,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100652712","nomad-gi-molecular-guided-non-operative-management-and-organ-preservation-strategy-after-precision-therapy-in-gastrointestinal-cancers-100652712","NCT07775859","NOMAD-GI: Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers","Safety and Efficacy of Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers: A Single-center Bidirectional Cohort Study","NOMAD-GI","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of study enrollment.\n2. Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer.\n3. Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to:\n\n   * Mismatch repair deficiency or microsatellite instability-high (dMMR\u002FMSI-H);\n   * Pathogenic or likely pathogenic POLE or POLD1 mutation;\n   * High programmed death ligand 1 combined positive score (PD-L1 CPS), when applicable to the tumor type and treatment strategy;\n   * Tumor mutational burden-high (TMB-H);\n   * Epstein-Barr virus-positive status (EBV-positive), when applicable;\n   * Human epidermal growth factor receptor 2 (HER2) positivity;\n   * Claudin 18.2 (CLDN18.2) positivity;\n   * Fibroblast growth factor receptor 2 (FGFR2) alteration;\n   * Mesenchymal-epithelial transition factor (MET) amplification or other actionable MET alteration;\n   * Neurotrophic tyrosine receptor kinase (NTRK) gene fusion;\n   * Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation;\n   * Other clinically actionable molecular alterations recognized according to contemporary clinical practice.\n4. Receipt of molecular biomarker-guided precision therapy before assessment for non-operative management or organ-preservation strategy. Precision therapy may include immune checkpoint inhibitor therapy, targeted therapy, or a combination of systemic therapies according to the participant's tumor type, molecular profile, clinical stage, and standard clinical practice.\n5. After completion or adequate exposure to precision therapy, achievement of a favorable clinical response that may support consideration of non-operative management or organ-preservation strategy, including clinical complete response (cCR), near-complete response (near-cCR), major tumor regression, or other predefined favorable response categories.\n6. Multidisciplinary team (MDT) evaluation has been performed to determine whether non-operative management, local treatment, organ-preservation strategy, or radical surgery is appropriate.\n7. Adequate clinical information is available for assessment of treatment response, including appropriate imaging, endoscopic evaluation, pathological evaluation, or other clinically indicated examinations.\n8. Ability and willingness to comply with the predefined surveillance and follow-up schedule.\n9. For the prospective cohort, written informed consent is obtained before enrollment and study-specific data collection.\n10. For the retrospective cohort, eligible clinical data are available in the institutional medical records and may be used according to institutional ethics approval and applicable regulations.\n\nExclusion Criteria:\n\n1. Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy.\n2. Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up.\n3. Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy.\n4. Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate.\n5. Inability or unwillingness to comply with the predefined follow-up schedule.\n6. Withdrawal of informed consent for prospective participants.\n7. Insufficient clinical information to determine eligibility, treatment response, treatment strategy, or follow-up outcomes.\n8. Patients with conditions that require immediate radical surgery or other urgent treatment according to multidisciplinary clinical assessment and who cannot safely undergo the predefined study evaluation.",{"count":96,"type":20},200,"3 Months","OBSERVATIONAL","The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers.\n\nPatients with actionable molecular biomarkers, including dMMR\u002FMSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled.\n\nAfter immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions.\n\nThe study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.",[101,27,102,60,103],"Gastrointestinal Cancer","Gastroesophageal Junction Cancer","Colorectal Cancer",[105,106,107,108,109,110,111,112,113],"Precision oncology","Molecular biomarkers","Gastrointestinal cancer","Non-operative management","Organ preservation","Immunotherapy","Targeted therapy","Watch and wait","Multidisciplinary treatment","2026-08-18",{"date":116,"type":32},"2026-08-20",{"date":118,"type":20},"2026-09-01",{"date":120,"type":20},"2031-09-01",{"name":122,"class":39},"Peking University Cancer Hospital & Institute",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":40},"100652597","ct-imaging-and-clinical-features-to-predict-outcomes-in-patients-with-gastric-cancer-100652597","NCT07776067","CT Imaging and Clinical Features to Predict Outcomes in Patients With Gastric Cancer","Prospective Validation of a CT Radiomics-Based Model Combined With Clinical Features for Prognosis Prediction in Gastric Cancer Patients","Inclusion Criteria:\n\nHistologically or pathologically confirmed gastric cancer and receiving treatment at the study center.\n\nAge ≥18 years. Complete pretreatment CT imaging data available from the study center.\n\nExclusion Criteria:\n\nPretreatment CT images of insufficient quality for analysis. Incomplete clinical data. Presence of another malignant tumor in addition to gastric cancer.",{"count":131,"type":20},600,"The goal of this prospective observational study is to evaluate how well a previously developed prediction model can estimate outcomes in adults with gastric cancer. The model combines information from computed tomography (CT) images obtained before treatment with routine clinical information. The main questions are how well the model predicts how long participants live after treatment begins and whether their cancer progresses.\n\nParticipants will receive their usual medical care. Researchers will collect pretreatment CT images, basic clinical and tumor information, laboratory and tumor marker results, treatment information, and follow-up outcomes obtained during routine care. These data will be entered into the predefined prediction model, and the model's predictions will be compared with what actually happens during follow-up.\n\nThe study will not change the participants' usual treatment. Model predictions will be used for research purposes only and will not be used to make treatment decisions.",[27],[135,136,137,138,139,140],"Computed Tomography","Radiomics","Prognostic Model","Overall Survival","Progression-Free Survival","Prospective Validation","2026-08-17",{"date":116,"type":32},{"date":144,"type":32},"2026-04-01",{"date":146,"type":20},"2027-04-01",{"name":148,"class":39},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":40},"100594933","phase-1-ibi343-combined-with-sintilimab-plus-chemotherapy-in-gastric-cancer-100594933","NCT07025889","IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer","IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)","Inclusion Criteria:\n\n* 1\\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.\n\n  2\\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.\n\n  3\\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric\u002Fgastroesophageal junction (G\u002FGEJ AC).\n\n  4\\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n\nExclusion Criteria:\n\n* 1\\. Has HER2-positive (defined as immunohistochemistry \\[IHC\\] 3+, or IHC 2+ and positive by in situ hybridization) disease.\n\n  2\\. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.\n\n  3\\. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).","75 Years",{"count":158,"type":20},55,[160,23],"PHASE1","This is a Single-arm, Open-label, Phase 1b\u002F2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",[27],[27,164,165],"IBI 343","Sintilimab",{"date":114,"type":32},{"date":168,"type":32},"2025-06-02",{"date":170,"type":20},"2028-06",{"name":172,"class":39},"Ruijin Hospital",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":40},"100579575","phase-2-safety-and-efficacy-study-of-sorbitol-with-neoadjuvant-chemotherapy-combined-with-tirellizumab-pd-1-inhibitor-in-patients-with-locally-advanced-gastric-cancer-100579575","NCT06826079","Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","SNCCTGC","Inclusion Criteria\n\n* Age: 18 years ≤ age ≤ 70 years, gender not restricted.\n* Written informed consent obtained from the patient.\n* Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type III GEJ cancer and Siewert type II GEJ cancer patients who do not require combined thoracotomy are eligible for inclusion.\n* ECOG PS score of 0-1.\n* Normal major organ function, meeting the following criteria:\n* Blood routine examination criteria (no blood or blood product transfusion within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):\n* HB ≥ 90 g\u002FL;\n* ANC ≥ 1.5×109\u002FL;\n* PLT ≥ 125×109\u002FL;\n* Biochemical examination criteria:\n* TBIL \\\u003C 1.5ULN;\n* ALT and AST \\\u003C 2.5ULN, and for patients with liver metastasis, \\\u003C 5ULN; serum Cr ≤ 1.25ULN or endogenous creatinine clearance rate \\> 50ml\u002Fmin (Cockcroft-Gault formula);\n* Fertile women must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.\n\nExclusion Criteria\n\n* Presence of distant organ metastasis and peritoneal disseminated metastasis.\n* Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease \\[such as colitis or Crohn's disease\\], diverticulitis \\[excluding diverticular disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]), except for patients with vitiligo or alopecia, provided that they have celiac disease that can be controlled through diet after consultation with the study doctor.\n* Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.\n* Patients preparing for or having previously undergone organ or bone marrow transplantation.\n* Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV\u002FHCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the ability of the subject to provide written informed consent.\n* Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose \\> 10mg\u002Fday prednisone or other equivalent efficacy hormones), and still using them within 2 weeks before enrollment.\n* Patients who have previously received platinum-based, fluorouracil-based chemotherapy or targeted therapy, patients whose target lesions have undergone radiotherapy during combination therapy, or patients who have previously received other PD-1 antibody treatment or other PD-1\u002FPD-L1 immune therapy.\n* Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);\n* Have experienced significant clinically significant bleeding symptoms or have a clear bleeding tendency within the last three months, such as a history of black stool or hematemesis, or are at high risk of bleeding due to conditions such as intestinal perforation, gastric perforation, or extensive ulcers, or have active gastric ulcers and a positive fecal occult blood test (++) ;\n* Have hypertension that cannot be well controlled with a single antihypertensive drug (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); have a history of unstable angina pectoris; have been newly diagnosed with angina pectoris within the last three months or have had a myocardial infarction within the last six months; have arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) and need long-term use of antiarrhythmic drugs or have New York Heart Association functional class ≥ II heart failure; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Urinalysis indicates proteinuria ≥ ++ and confirmed 24-hour urine protein quantification \\> 1.0 g;\n* Have long-term non-healing wounds or incompletely healed fractures;\n* Have abnormal coagulation function and a bleeding tendency (INR must be within the normal range without anticoagulants 14 days before enrollment); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is allowed if the international normalized ratio (INR) of prothrombin time is ≤ 1.5;\n* Have experienced arterial or venous thrombotic events within the last year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by previous chemotherapy catheterization and judged by the investigator to have healed), and pulmonary embolism, etc.;\n* Have a history of abuse of psychotropic drugs and are unable to quit or have mental disorders;\n* Have serious concomitant diseases that, in the judgment of the investigator, pose a significant risk to the patient's safety or affect the patient's ability to complete the study;\n* Pregnant or lactating women.","70 Years",{"count":86,"type":20},[23],"The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are:\n\nDoes sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer?\n\nResearchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer.\n\nParticipants will:\n\nTake sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).",[186,27,110,187],"Gastric Junction Adenocarcinoma","Neoadjuvant Therapies",[189,190,191,192],"sorbitol","tislelizumab","SOX","gastric cancer","2026-08-16",{"date":114,"type":32},{"date":196,"type":32},"2024-11-01",{"date":198,"type":20},"2029-08-01",{"name":148,"class":39},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":40},"100300428","phase-1-administering-peripheral-blood-lymphocytes-transduced-with-a-murine-t-cell-receptor-recognizing-the-g12v-variant-of-mutated-ras-in-hla-a1101-patients-100300428","NCT03190941","Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients","A Phase I\u002FII Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients","* INCLUSION CRITERIA:\n* Measurable (per RECIST V1.1 criteria, metastatic, or unresectable malignancy expressing G12V mutated KRAS as assessed by one of the following methods: RT-PCR on tumor tissue, tumor DNA sequencing, or any other CLIA-certified laboratory test on resected tissue. Patients shown to have tumors expressing G12V mutated NRAS and HRAS will also be eligible as these oncogenes share complete amino acid homology with G12V mutated KRAS for their first 80 N-terminal amino acids, completely encompassing the target epitope.\n* Patients must be HLA-A\\*11:01 positive as confirmed by the NIH Department of Transfusion Medicine.\n* Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.\n* Patients must have:\n\n  * previously received standard systemic therapy for their advanced cancer and have been either non-responders or have recurred, specifically:\n\n    * Patients with metastatic colorectal cancer must have had at least two systemic chemotherapy regimens that include 5FU, leucovorin, bevacizumab, oxaliplatin, and irinotecan (or similar agents), or have contraindications to receiving those medications.\n    * Patients with pancreatic cancer must have received gemcitabine, 5FU, and oxaliplatin (or similar agents), or have contraindications to receiving those medications.\n    * Patients with non-small cell lung cancer (NSCLC) must have had appropriate targeted therapy as indicated by abnormalities in ALK, EGFR, or expression of PDL- 1. Other patients must have had platinum-based chemotherapy.\n    * Patients with ovarian cancer or prostate cancer must have had approved first-line chemotherapy.\n\nOR\n\n* declined standard treatment\n* Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients\n\nwith surgically resected brain metastases are eligible.\n\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1\n* Patients must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for women and for 4 months after treatment for men.\n* Women of child-bearing potential must be willing to undergo pregnancy testing prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology\n\n  * ANC greater than 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry\n\n  * Serum ALT\u002FAST less than or equal to 5.0 times ULN\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL.\n* Patients must have either an eGFR \\> 60 mL\u002Fm (based on serum creatinine and lab nomogram) or a formal 6-24h CrCl \\> 60 mL\u002Fm.\n* Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03C0277.\n\nEXCLUSION CRITERIA:\n\n* Large volume pulmonary irradiation.\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% or DLCO less than 60%.\n* Patients who are receiving any other investigational agents.","72 Years",{"count":209,"type":20},110,[160,23],"Background:\n\nA new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells.\n\nObjective:\n\nTo see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors.\n\nEligibility:\n\nAdults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors.\n\nDesign:\n\nIn another protocol, participants will:\n\nBe screened\n\nHave cells harvested and grown\n\nHave leukapheresis\n\nIn this protocol, participants will have the procedures below.\n\nParticipants will be admitted to the hospital.\n\nOver 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest.\n\nA few days later, participants will get the anti-KRAS G12V mTCR cells via catheter.\n\nFor up to 3 days, participants will get a drug to make the cells active.\n\nA day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin.\n\nParticipants will recover in the hospital for 1-2 weeks. They will have lab and blood tests.\n\nParticipants will take an antibiotic for at least 6 months.\n\nParticipants will have visits every few months for 2 years, and then as determined by their doctor.\n\nVisits will be 1-2 days. They will include lab tests, imaging studies, and physical exam. Some visits may include leukapheresis or blood drawn.\n\nParticipants will have blood collected over several years.\n\n...",[213,27,101,214,215],"Pancreatic Cancer","Colon Cancer","Rectal Cancer",[217,218,219,220,110],"KRAS","HRAS","NRAS","Cell Therapy","2026-08-15",{"date":114,"type":32},{"date":224,"type":32},"2017-09-21",{"date":226,"type":20},"2028-06-29",{"name":228,"class":229},"National Cancer Institute (NCI)","NIH",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":16,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":40},"100405330","surgery-in-gastrointestinal-stromal-tumors-gists-for-treatment-tumor-modeling-and-genomic-analysis-100405330","NCT04557969","Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","* INCLUSION CRITERIA:\n* Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.\n* Age \\>= 6 years\n* ECOG performance status \\\u003C= 2 (Karnofsky or Lansky \\>= 60%)\n* Ability of participant or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n\\- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.","6 Years",{"count":239,"type":20},400,"Objective:\n\nTo follow people with GISTs and collect tumor tissue so that it can be studied in the lab.\n\nEligibility:\n\nPeople age 6 and older who have a GIST.\n\nDesign:\n\nParticipants will be screened with a review of their medical records and samples.\n\nParticipants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies.\n\nParticipants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained.\n\nParticipants may speak with a genetic counselor. They may have genetic testing.\n\nParticipants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek.\n\nParticipants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis.\n\nParticipants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery.\n\nIf a participant has surgery, tumor tissue samples and research specimen will be taken.\n\nIf a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.",[27,242,243,244,245],"Gastric Neoplasm","Gastrointestinal Stromal Sarcoma","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor (GIST)",[247,248,249,250,251,252],"Tyrosine Kinase Inhibitor (TKI) Therapy","Wild-Type GISTs (WT GISTs)","PDGFRA Mutation","KIT Mutation","SDH Mutation","Natural History","2026-08-14",{"date":141,"type":32},{"date":256,"type":32},"2020-12-18",{"date":258,"type":20},"2040-12-30",{"name":228,"class":229},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":40},"100651849","home-based-whole-course-multimodal-prehabilitation-based-on-5g--artificial-intelligence-mobile-health-100651849","NCT07764523","Home-based Whole Course Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health","Whole-course Multi-modal Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home-based on 5G + AI Mobile Health (mHealth): a Multicenter Prospective Randomized Control Trial","mHealth prehab","Inclusion Criteria:\n\n* Aged 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Histologically confirmation of gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ carcinomas, eligibility is strictly confined to those presenting with Siewert type III tumors or Siewert type II tumors that do not mandate a concurrent thoracotomy\n* Multidisciplinary team (MDT) referral for neoadjuvant chemotherapy prior to gastrectomy\n* For female participants of childbearing potential, a negative serum pregnancy test must be confirmed within 7 days prior to the initial administration of neoadjuvant therapy\n* Capacity to comprehend and voluntarily sign a written informed consent form\n* Ability to use digital technology (e.g., smart phones, wearable devices) independently or with the assistance of family members\n\nExclusion Criteria:\n\n* Distant metastasis\n* Severe cardiac dysfunction (preoperative LVEF \\\u003C 30% or NYHA classification IV), severe liver dysfunction (Child-Pugh C grade), severe kidney dysfunction (preoperative CRRT was received), ASA grade IV or above; 6MWD ≤ 250 meters\n* Within 6 months before enrollment, the patient had experienced cerebral hemorrhage, cerebral infarction, TIA, or suffered from central nervous system diseases or mental disorders, and was unable to cooperate in completing neoadjuvant therapy and prehabilitation\n* Presence of severe systemic infections (e.g., multiple organ dysfunction syndrome \\[MODS\\]) or active infectious diseases (e.g., tuberculosis)\n* Emergency surgery is required due to complications of the tumor (e.g. bleeding, perforation, obstruction)\n* Simultaneous tumors or other diseases requiring simultaneous surgery (excluding laparoscopic cholecystectomy)\n* Patients who are participating in any other clinical trials (except observational, non-interventional clinical study)",{"count":269,"type":20},328,[271],"NA","The whole course management of gastric caner patients receiving neoadjuvant therapy frequently hinders by challenges such as inaccurate exercise plans, inadequate nutritional supplementary, limited access to timely psychological support, the toxicity of chemtherapy and poor adherence to prehabilitation protocols. AI (Agent Intelligence) have already been demonstrated remarkable capabilities in personalized patient education and improving compliance to perhabilitation protocols. To date, high quality evidence from randomized clinical trials investigating the clinical and oncological benefit of prehabilitation based on 5G+AI mobile health for this patient cohort is lacking.",[27,274],"Prehabilitation",[192,276,277],"prehabilitation","mobile health","2026-08-12",{"date":253,"type":32},{"date":281,"type":20},"2026-08-01",{"date":283,"type":20},"2030-05-30",{"name":285,"class":39},"The Affiliated Hospital of Qingdao University",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100598066","phase-1-a-study-of-mrg007-arr-217-in-patients-with-advanced-solid-tumors-100598066","NCT07066657","A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors","An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","1. Willing to sign the informed consent form and follow the requirements specified in the protocol.\n2. Life expectancy ≥ 3 months.\n3. Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.\n4. Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.\n5. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n6. The score of ECOG for performance status is 0 or 1.\n7. Organ functions and coagulation function must meet the basic requirements.\n8. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n1. Patients with more than one cancer.\n2. Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives, whichever is longer; investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose.\n3. ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment\n4. Symptomatic Central nervous system and\u002For meninges metastasis.\n5. History of severe cardiovascular diseases\n6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3 months prior to the first dose, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis\n7. History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.\n8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion\n9. Infection of active hepatitis B, active hepatitis C, or HIV\n10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment\n11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody.\n12. Other situations that are not suitable to participate a clinical trial per investigator's judgement\n13. Additional protocol-defined exclusion criteria apply",{"count":294,"type":20},572,[160],"This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.",[298,103,27,213],"Locally Advanced or Metastatic Solid Tumors",[300,301,302,303,304],"MRG007","Advanced or Metastatic Solid Tumors","CDH17","ARR-217","ADC",{"date":306,"type":32},"2026-08-13",{"date":308,"type":32},"2025-07-25",{"date":310,"type":20},"2030-12",{"name":312,"class":85},"ArriVent BioPharma, Inc.",21,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":331,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd","130 Years",{"count":323,"type":20},454,[23],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[58,27,327,328,103,329,330],"Metastatic Castration-resistant Prostate Cancer","Ovarian Cancer","Urothelial Cancer","Biliary Tract Cancer",[332,333,334,335,336],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)",{"date":306,"type":32},{"date":339,"type":32},"2022-09-06",{"date":341,"type":20},"2027-10-01",{"name":343,"class":85},"AstraZeneca",96,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":353,"type":20},250,[160],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[53,357,358,359,360,361,59,362,58,54,363,57,103,27,364,365,366,367,368,65,328,369],"Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Sarcoma","Castration Resistant Prostatic Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-08-10",{"date":372,"type":32},"2026-08-11",{"date":374,"type":32},"2024-03-06",{"date":376,"type":20},"2028-10",{"name":378,"class":85},"MacroGenics",12,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100651095","preoperative-home-based-multimodal-prehabilitation-based-on-5g--artificial-intelligence-mobile-health-100651095","NCT07755917","Preoperative Home-based Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health","Preoperative Multi-mode Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home Based on 5G + AI Mobile Health (mHealth): A Multicenter RCT","Inclusion Criteria:\n\n* Aged 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Histologically confirmation of gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ carcinomas, eligibility is strictly confined to those presenting with Siewert type III tumors or Siewert type II tumors that do not mandate a concurrent thoracotomy\n* Surgery is planned after neoadjuvant therapy\n* Capacity to comprehend and voluntarily sign a written informed consent form\n* Ability to use digital technology (e.g., smart phones, wearable devices) independently or with the assistance of family members\n\nExclusion Criteria:\n\n* Distant metastasis\n* Severe cardiac dysfunction (preoperative LVEF \\\u003C 30% or NYHA classification IV), severe liver dysfunction (Child-Pugh C grade), severe kidney dysfunction (preoperative CRRT was received), ASA grade IV or above; 6MWD ≤ 250 meters\n* Within 6 months before enrollment, the patient had experienced cerebral hemorrhage, cerebral infarction, TIA, or suffered from central nervous system diseases or mental disorders, and was unable to cooperate in completing neoadjuvant therapy and prehabilitation\n* Presence of severe systemic infections (e.g., multiple organ dysfunction syndrome \\[MODS\\]) or active infectious diseases (e.g., tuberculosis)\n* Emergency surgery is required due to complications of the tumor (e.g. bleeding, perforation, obstruction)\n* Simultaneous tumors or other diseases requiring simultaneous surgery (excluding laparoscopic cholecystectomy)\n* Patients who are participating in any other clinical trials (except observational, non-interventional clinical study)",{"count":388,"type":20},490,[271],"The goal of this prospective, multicenter, open-label randomized controlled clinical trial is to evaluate whether a home-based, digitally supervised multi-modal prehabilitation intervention can improve functional capacity, treatment tolerance, and short- and long-term clinical outcomes in gastric cancer patients who have completed 2-4 cycles of neoadjuvant chemotherapy and are scheduled for radical gastrectomy.",[27,274],[192,276],"2026-08-07",{"date":370,"type":32},{"date":396,"type":20},"2026-08-31",{"date":398,"type":20},"2030-09-01",{"name":285,"class":39},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":421,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100647108","a-study-of-shy-onc6-a-novel-proteasome-inhibitor-in-adults-with-advanced-or-metastatic-solid-tumors-100647108","NCT07705334","A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors","A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors","Luca-1","Inclusion Criteria:\n\n* Male or female ≥18 years of age.\n* Life expectancy \\>3 months.\n* ECOG performance status 0-1.\n* Histologically\u002Fcytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant\u002Funsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted.\n* ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3).\n* Accessible tumor for biopsy\n* Adequate organ\u002Fbone marrow function.\n* Willingness and ability to provide informed consent.\n* Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential.\n* Male participants must use barrier contraception or abstinence and not donate sperm through 90 days after last dose.\n\nExclusion Criteria:\n\n* High-risk cardiovascular disease.\n* Concurrent anti-cancer treatment.\n* Active infection requiring systemic treatment within 2 weeks pre-dose.\n* History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).\n* Active HBV (HBV-DNA \\>ULN), HCV (HCV-RNA \\>ULN), or HIV (well-controlled HIV with CD4 ≥350 cells\u002FµL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months.\n* Compromised pulmonary function within 6 months pre-dose .\n* Pregnancy or breastfeeding.\n* Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.\n* Major surgery ≤4 weeks pre-dose.\n* Unable to swallow tablets or conditions affecting GI absorption.\n* Any medical or psychiatric disorders affecting compliance and\u002For interpretation of study results.\n* Persistent toxicities from prior anti-cancer therapy (exceptions apply)\n* Clinically significant corneal disease.\n* Unable to comply with prohibited concomitant medication restrictions.",{"count":409,"type":20},30,[160],"This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).",[301,413,414,214,27,415,416,417,418,419,420],"Triple Negative Breast Cancer (TNBC)","HR+ Breast Cancer","Hepatecellular Carcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Mesothelioma","Pancreatic Carcinoma Metastatic","Hormone Refractory Prostate Cancer","Soft Tissue Sarcomas",[422,423],"Proteasome Inhibitor","Solid Tumors","2026-08-06",{"date":370,"type":32},{"date":427,"type":32},"2026-06-24",{"date":429,"type":20},"2028-05-15",{"name":431,"class":85},"SHY Therapeutics",4,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":353},"100572300","study-of-tdxd-chemotherapy-pembrolizumab-and-trastuzumab-in-first-line-metastatic-her2-positive-gastric-or-gastroesophageal-junction-cancer-100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":441,"type":20},726,[443],"PHASE3","This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[27,102],[447,448,449,450,451],"Enhertu","Trastuzumab Deruxtecan","Chemotherapy","DS-8201a","HER2 positive",{"date":370,"type":32},{"date":454,"type":32},"2025-02-27",{"date":456,"type":20},"2030-02-01",{"name":84,"class":85},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":466,"briefSummary":467,"conditions":468,"keywords":472,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100610406","phase-1-a-study-of-stro-004-in-adults-with-refractoryrecurrent-metastatic-cancer-100610406","NCT07227168","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",{"count":96,"type":20},[160],"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",[469,470,60,27,103,471,57,58,329],"Head and Neck Squamous Cell Carcinoma HNSCC","Non-Small Cell Lung Cancer NSCLC","Pancreatic Ductal Adenocarcinoma (PDAC)",[473,474,475,304],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","2026-08-04",{"date":424,"type":32},{"date":479,"type":32},"2025-11-07",{"date":481,"type":20},"2028-04",{"name":483,"class":85},"Sutro Biopharma, Inc.",9,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":511},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":493,"type":20},104,[271],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[497,498,499,65,57,214,58,60,500,27,501,502,64,55,328,213,62,215,362],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Gall Bladder Cancer","Kidney Cancer","Liver Cancer",{"date":504,"type":32},"2026-08-05",{"date":506,"type":32},"2026-02-11",{"date":508,"type":20},"2027-08-31",{"name":510,"class":39},"Alliance for Clinical Trials in Oncology",18,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":16,"minAge":520,"maxAge":521,"enrollmentInfo":522,"targetDuration":4,"studyType":21,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":40},"100384380","surgical-treatment-for-obesity-related-disease-and-onco-metabolic-surgery-100384380","NCT04284943","Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery","A Randomized Controlled Trial Comparing Billroth II Reconstruction Versus Conventional Roux-en-Y Reconstruction Versus Long Limb Roux-en-Y Reconstruction for Glycemic Control in Patients With Concurrent Type 2 Diabetes and Gastric Cancer","STARDOM","Inclusion Criteria:\n\n* Distal gastric adenocarcinoma diagnosed pathologically under preoperative endoscopic biopsy, and clinical stage I-II\n* Body mass index ≥ 23 kg\u002Fm2\n* Type 2 diabetes and HbA1c ≥ 6.5%\n\nExclusion Criteria:\n\n* Insulin usage for glycemic control at the time of screening evaluation\n* Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy)\n* Abdominal, thoracic, pelvic and\u002For obstetric-gynecologic surgery within 3 months\n* Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible\n* Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease\n* Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency\n* Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders\n* Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months\n* Severe pulmonary disease defined as FEV1 \\\u003C50% of predicted value\n* Anemia defined as hemoglobin less than 8 in females and 10 in males\n* Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion\n* Frail elderly (Rockwood Clinical Frailty Scale ≥5)\n* Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study\n* Unable to understand the risks, realistic benefits and compliance requirements of each program\n* Use of investigational therapy or participation in any other clinical trial within 3 months\n* Geographic inaccessibility\n* Pregnancy","20 Years","69 Years",{"count":523,"type":20},120,[271],"This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.",[27,527],"Diabetes Mellitus, Type 2",[27,527,529],"Subtotal Gastrectomy",{"date":393,"type":32},{"date":532,"type":32},"2020-12-01",{"date":534,"type":20},"2027-12",{"name":536,"class":39},"Korea University Anam Hospital",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":21,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":432},"100600759","phase-2-total-neoadjuvant-therapy-with-short-course-radiation-therapy-in-gastric-cancer-100600759","NCT07101666","Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer","TNT-SHORT","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically gastric adenocarcinoma. (Siewert III acceptable: the bulk of tumor should be in stomach; gastric tumors with extension to the gastroesophageal junction are permitted.) Patients with T1-4N0-3 are eligible.\n* Known T-stage defined by EUS. Must have had CT of the chest\u002Fabdomen\u002Fpelvis with IV contrast (or PET\u002FCT if unable to receive iodinated contrast).\n* Medically eligible to receive SOC chemotherapy.\n* At least 18 years of age.\n* ECOG performance status ≤ 2.\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockroft Gault calculation\n* The effects of the various chemotherapy agents used in this study on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and one month after completion of the study.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.\n* Prior surgery to the esophagus or stomach.\n* Siewert I-II GE junction tumor.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the SOC chemotherapy used in the study.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that are considered clinically significant as determined by the treating physician.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of study entry.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.",{"count":545,"type":20},20,[23],"Standard treatment for patients with early stage gastric cancer consists of perioperative chemotherapy and surgical resection. If radiation therapy is administered in the adjuvant setting, the radiated area is often large and associated with significant toxicity.\n\nIn this study, the investigators propose the addition of short course radiation therapy (SCRT) to chemotherapy in the neoadjuvant setting. The investigators hypothesize that this regimen of Total Neoadjuvant Therapy (TNT) will result in a higher rate of complete response (both pathologic and clinical), with less toxicity.",[27],[550,551],"Gastric cancer","SCRT","2026-08-03",{"date":424,"type":32},{"date":555,"type":20},"2026-10-31",{"date":557,"type":20},"2031-04-30",{"name":559,"class":39},"Washington University School of Medicine",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":21,"phases":569,"briefSummary":570,"conditions":571,"keywords":576,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":588},"100586075","phase-1-idov-immune-for-advanced-solid-tumors-100586075","NCT06910657","IDOV-Immune for Advanced Solid Tumors","A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.\n* ECOG performance status ≤ 1.\n* Measurable disease per RECIST v1.1.\n* Adequate organ and bone marrow function.\n* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).\n* Negative pregnancy test for women of childbearing potential.\n* Agreement to use effective contraception during treatment and for 3 months after.\n* Ability to provide informed consent and comply with study requirements.\n\nKey Exclusion Criteria:\n\n* Prior treatment with an oncolytic virus.\n* Active or recent vaccinia virus infection or smallpox\u002Fmonkeypox vaccination within 10 years.\n* Active uncontrolled infection requiring systemic treatment.\n* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).\n* Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).\n* Active or symptomatic autoimmune disease requiring systemic therapy.\n* Active or untreated CNS metastases (unless stable per protocol).\n* Significant cardiac disease (e.g., NYHA Class III\u002FIV heart failure).\n* Interstitial lung disease or prior pneumonitis requiring steroids.\n* Conditions requiring chronic immunosuppressive therapy.\n* Severe skin disorders or history of pancreatitis.\n* Bleeding disorders or history of recent serious thromboembolic events.\n* Any medical or psychiatric condition that could interfere with study participation.",{"count":568,"type":20},78,[160],"This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.\n\nThe purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.\n\nParticipants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.\n\nThis study is being conducted at multiple sites in the United States and Australia.",[103,213,54,328,27,60,367,572,65,362,59,64,62,573,574,575],"Renal Cell Carcinoma","Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[577,578,358,579,110,580],"Oncolytic Virus Therapy","Advanced Solid Tumors","Refractory Cancer","Vaccinia Virus",{"date":504,"type":32},{"date":583,"type":32},"2025-08-25",{"date":585,"type":20},"2027-05-31",{"name":587,"class":85},"ViroMissile, Inc.",5,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":21,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":484},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  • AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3\n\n* Has a histologically or cytologically confirmed non-squamous NSCLC;\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2 - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease.\n\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  • The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\n  • Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-9 - Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\nThe confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\nPatient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n\n\\- No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nTreatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* Clinically significant history or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":597,"type":20},917,[160],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[601,602,103,603,27,604,60,55,330],"Advanced or Metastatic Solid Tumor","Pancreatic Ductal Adenocarcinoma","Non-small Cell Lung Cancer","Alveolar Soft Part Sarcoma",{"date":504,"type":32},{"date":607,"type":32},"2021-06-01",{"date":609,"type":20},"2027-06",{"name":611,"class":85},"Taiho Pharmaceutical Co., Ltd.",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":618,"targetDuration":620,"studyType":98,"phases":4,"briefSummary":621,"conditions":622,"keywords":623,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":629,"leadSponsor":631,"locationsCount":40},"100650437","prospective-assessment-of-alignment-between-multimodal-artificial-intelligence-and-multidisciplinary-team-decisions-in-gastrointestinal-oncology-100650437","NCT07746830","Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology","Inclusion Criteria:\n\n1. Aged 18 years or older, with no restriction based on sex.\n2. Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.\n3. Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.\n4. A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.\n5. At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.\n6. A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.\n7. Willing and able to understand the study and provide dated written informed consent.\n\nExclusion Criteria:\n\n1. Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.\n2. The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.\n3. A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.\n4. Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.\n5. A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.\n6. The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.\n7. The participant is unable to provide valid informed consent because of impaired consciousness, severe cognitive impairment, or another reason, and no ethics-approved proxy consent procedure is available for this study.\n8. The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.\n9. Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.",{"count":619,"type":20},69,"3 Years","This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.",[27,103,101],[103,27,624,625],"MDT","Artificial Intelligence","2026-07-31",{"date":504,"type":32},{"date":504,"type":20},{"date":630,"type":20},"2028-08-05",{"name":632,"class":39},"Shanghai Minimally Invasive Surgery Center",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":21,"phases":642,"briefSummary":643,"conditions":644,"keywords":645,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":659},"100532986","phase-2-azd0901-in-participants-with-advanced-solid-tumours-expressing-claudin182-100532986","NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.",{"count":641,"type":20},226,[23],"The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[27,102,330,602],[550,646,647,330,648,649,650],"Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","Claudin 18.2","AZD0901","2026-07-28",{"date":653,"type":32},"2026-07-29",{"date":655,"type":32},"2023-12-13",{"date":657,"type":20},"2027-06-28",{"name":343,"class":85},52,{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":21,"phases":669,"briefSummary":670,"conditions":671,"keywords":676,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":702,"startDateStruct":703,"completionDateStruct":705,"leadSponsor":707,"locationsCount":709},"100377763","phase-1-study-of-inbrx-106-and-inbrx-106-in-combination-with-pembrolizumab-keytruda-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-hexavalent-ox40-agonist-100377763","NCT04198766","Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1\u002F2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","Select Inclusion Criteria:\n\n* Males or females aged ≥18 years.\n* Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.\n* Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G\u002FGEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.\n* Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G\u002FGEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.\n* For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1\u002FL1 regimen.\n* For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1\u002FL1 in curative (neo-adjuvant\u002Fadjuvant) setting is allowed only if completed \\>\u002F= 6 months prior to progression to local recurrence or metastatic disease.\n* For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.\n* All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.\n* PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.\n* Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.\n\nSelect Exclusion Criteria:\n\n* Prior exposure to OX40 agonists. Exposure to anti-PD-1 and\u002For anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.\n* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.\n* Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)\n* Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.\n* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.\n* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.\n* Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n* Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\\u003C92% on room air.\n* Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.\n* Major surgery within 4 weeks prior to enrollment on this trial.\n* Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.\n* Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n* Additional in- and exclusion criteria per protocol.",{"count":668,"type":20},340,[160,23],"This is a Phase 1\u002F2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.",[672,673,55,54,27,572,674,675],"Solid Tumor","Non-Small Cell Lung Cancer","Urothelial Carcinoma","Resectable Non-Small-Cell Lung Cancer",[677,678,423,55,64,673,679,680,681,682,449,110,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,359,699,700,701],"Phase 1 and Phase 2","Phase 1 and Phase 2 Clinical Trial","OX40 receptor agonist","PD-L1 positive","Pembrolizumab","Keytruda","HNSCC","Oropharyngeal cancer","Hypopharyngeal cancer","Oral cancer","INBRX-106","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Squamous Cell","Head and Neck Neoplasms","Neoplasms by Site","Carcinoma","Carcinoma, Squamous Cell","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents, Immunological","Antineoplastic Agents","NSCLC","Neoadjuvant","Adjuvant",{"date":653,"type":32},{"date":704,"type":32},"2019-12-10",{"date":706,"type":20},"2033-07",{"name":708,"class":85},"Inhibrx Biosciences, Inc",42,{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":4,"eligibilityCriteria":716,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":717,"targetDuration":4,"studyType":21,"phases":719,"briefSummary":720,"conditions":721,"keywords":725,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":735,"startDateStruct":736,"completionDateStruct":738,"leadSponsor":740,"locationsCount":742},"100326192","phase-1-a-study-of-bispecific-antibody-mcla-158-in-patients-with-advanced-solid-tumors-100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease. • Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n* No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) or KRAS amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n* A microsatellite stable (MSS) tumor.\n* Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including:\n\n  1. Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine,\n  2. Targeted therapy with an anti-VEGF therapy\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002F RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  i. Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n\nii. Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina. History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  i. Active hepatitis B infection (hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n\nii. Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n\n• Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":718,"type":20},560,[160,23],"This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[722,103,27,723,699,683,724,60],"Advanced\u002FMetastatic Solid Tumors","Gastroesophageal-junction Cancer","Head and Neck Squamous Cell Carcinoma",[726,727,728,729,730,731,732,733,734],"Bispecific antibody","First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","EGFR","LGR5",{"date":653,"type":32},{"date":737,"type":32},"2018-05-02",{"date":739,"type":20},"2028-11",{"name":741,"class":85},"Merus B.V.",54]