[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,58,0,25,[9,45,78,114,145,207,230,254,289,310,344,364,384,407,429,454,478,516,540,572,595,622,646,670,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":4,"leadSponsor":41,"locationsCount":44},"100156813","acquisition-of-blood-and-tumor-tissue-samples-from-patients-with-gastrointestinal-cancer-100156813",false,"NCT01313442","Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer","Acquisition of Data, Blood, and Tumor Tissue Samples From Patients With Gastrointestinal Cancer","* INCLUSION CRITERIA:\n* Individuals 18 years of age and older\n* Individuals with a diagnosis of cancer\n* Individuals must be able to understand and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n-None","ALL","18 Years",{"count":20,"type":21},550,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas, and colon. Researchers are interested in evaluating how active the immune system is in trying to fight the cancer by studying blood and tumor tissue donated from individuals who have been diagnosed with gastrointestinal cancers.\n\nObjectives:\n\n\\- To collect blood and tumor samples from individuals who have been diagnosed with gastrointestinal cancers in order to study the immune system s response to the cancer.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who have been diagnosed with throat, stomach, gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the National Institutes of Health.\n\nDesign:\n\n* The study will require at least one but no more than four visits to the National Institutes of Health Clinical Center.\n* Participants will be screened with a physical examination and medical history, and will provide a baseline blood sample for study.\n* Participants will provide additional blood samples 2 and 4 months after the baseline sample, as well as a final sample at the completion of the treatment protocol.\n* Participants will provide tumor tissue samples only if they undergo a surgical procedure related to the treatment for their gastrointestinal cancer.\n* No treatment will be provided as part of this protocol.",[25,26,27],"Non-GI Cancers","Cancer of Gastrointestinal Tract","Gastrointestinal Cancer",[29,30,31,32,27,33],"Gut Microbiota","Analysis of immune subsets with regard to their function","Samples","Natural History","Gastrointestinal Tract Cancer","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2011-03-02",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100633240","study-of-high-precision-evaluation-of-molecular-residual-disease-through-a-platform-for-cancer-tracking-and-interception-sherlock-100633240","NCT07524114","Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)","SHERLOCK","Inclusion Criteria:\n\n1. Patients with histopathological confirmation of cancer. Patients whose diagnosis are made by cytology may also be considered for this study. For tumor types that are typically diagnosed using unequivocal imaging findings or biomarker profiles (e.g. hepatocellular cancer, uveal melanoma), they can be eligible without histopathological or cytological confirmation.\n2. Patients must have cancer that is planned for or has undergone curative intent treatment (e.g. surgery, definitive radiation, definitive chemoradiation, adjuvant radiation, adjuvant chemotherapy, adjuvant chemoradiation, etc). Curative intent treatment must be completed within 12 months of study entry. For patients on adjuvant\u002Fmaintenance endocrine or biological therapy (e.g. bevacizumab, immunotherapy, etc), enrollment within 12 months of completion of curative intent treatment is allowed.\n3. Patient must be ≥ 18 years old.\n4. All patients must have signed and dated an informed consent form.\n\nExclusion Criteria:\n\n1\\. History of another active invasive cancer within 2 years prior to study enrolment. Exceptions include squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 2 years.",{"count":53,"type":21},7000,"This study will collect, annotate, and sequence biospecimens (blood, tissue, urine, saliva and surgery drainage) from patients across different cancer types to detect molecular residual disease (MRD). Imaging scans and clinical data will also be gathered. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types. Results of ctDNA testing will be provided for clinical decisions and to determine eligibility for other linked interventional interception therapeutic studies, each of which will have a separate protocol.",[56,57,58,59,60,61,27,62,63,64],"Breast Cancer","Lung Cancer","Melanoma","Gynecologic Cancer","Genitourinary Cancer","Pancreatobiliary Cancer","Head and Neck Cancer","Rare Cancer","Unknown Primary Tumors",[66,67,68],"Minimal Residual Disease","Liquid Biopsy","Circulating Tumor DNA","2026-08-19",{"date":37,"type":38},{"date":72,"type":38},"2026-03-31",{"date":74,"type":21},"2031-03-31",{"name":76,"class":77},"University Health Network, Toronto","OTHER",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":88,"studyType":22,"phases":4,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"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":87,"type":21},200,"3 Months","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.",[27,91,92,93,94],"Gastric Cancer","Gastroesophageal Junction Cancer","Esophageal Cancer","Colorectal Cancer",[96,97,98,99,100,101,102,103,104],"Precision oncology","Molecular biomarkers","Gastrointestinal cancer","Non-operative management","Organ preservation","Immunotherapy","Targeted therapy","Watch and wait","Multidisciplinary treatment","NOT_YET_RECRUITING","2026-08-18",{"date":35,"type":38},{"date":109,"type":21},"2026-09-01",{"date":111,"type":21},"2031-09-01",{"name":113,"class":77},"Peking University Cancer Hospital & Institute",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":125,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":44},"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":123,"type":21},110,"INTERVENTIONAL",[126,127],"PHASE1","PHASE2","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...",[130,91,27,131,132],"Pancreatic Cancer","Colon Cancer","Rectal Cancer",[134,135,136,137,101],"KRAS","HRAS","NRAS","Cell Therapy","2026-08-15",{"date":106,"type":38},{"date":141,"type":38},"2017-09-21",{"date":143,"type":21},"2028-06-29",{"name":42,"class":43},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":153,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":124,"phases":156,"briefSummary":158,"conditions":159,"keywords":179,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":155,"type":21},30,[127,157],"PHASE3","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[160,161,162,163,164,27,165,166,167,168,169,170,171,172,173,174,175,176,177,178],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour","Pancreatic Diseases",[180,181,167,182,183,184,185,186,187,188,164,189,190,191,192,193,194,195,196],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-08-13",{"date":199,"type":38},"2026-08-17",{"date":201,"type":38},"2026-04-01",{"date":203,"type":21},"2029-10",{"name":205,"class":77},"Cancer Research UK",27,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":124,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":229},"100561940","phase-1-study-of-patritumab-deruxtecan-in-participants-with-gastrointestinal-cancers-mk-1022-011-herthena-pantumor02-100561940","NCT06596694","Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following cancers:\n\n  * Unresectable or metastatic colorectal cancer.\n  * Advanced and\u002For unresectable biliary tract cancer (BTC)\n  * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy\n  * Locally advanced unresectable or metastatic gastroesophageal cancer\n* Has received prior therapy for the cancer.\n* Has recovered from any side effects due to previous cancer treatment\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and\u002For suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n* Has evidence of any leptomeningeal disease\n* Has clinically significant corneal disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection",{"count":215,"type":21},180,[126,127],"Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:\n\n* About the safety and how well people tolerate of patritumab deruxtecan\n* How many people have the cancer respond (get smaller or go away) to treatment",[27],"2026-08-05",{"date":221,"type":38},"2026-08-07",{"date":223,"type":38},"2024-11-03",{"date":225,"type":21},"2028-12-07",{"name":227,"class":228},"Merck Sharp & Dohme LLC","INDUSTRY",62,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":44},"100515770","immunobiology-blood-and-tissue-collection-of-upper-aerodigestive-malignancies-100515770","NCT05995821","Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies","Inclusion Criteria:\n\n* Subjects with a pathologically confirmed or clinically suspected upper aerodigestive malignancy who may be candidates for known or potentially immunomodulating treatments\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with known significant contraindications for venipuncture (e.g., hemoglobin \\\u003C8.5 g\u002FdL) will be excluded from the blood collection component of the study\n* Patients with known significant contraindications for biopsy (e.g., severe bleeding diathesis) will be excluded from the tissue biopsy component of the study\n* Patients with known significant contraindications for bronchoscopy (e.g., airway concerns, significant cardiac disease) will be excluded from the bronchoscopy component of the study\n* Unable or unwilling to read English and complete forms\u002Fquestionnaires",{"count":237,"type":21},1250,"This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving treatments known or thought to have an effect on the immune system.\n\nThe goal of this discovery and exploratory study is to:\n\n* Understand changes in the immune system associated with various cancer treatments, in order to better design new therapies or tests to predict how these treatments might work.\n* Identify risk factors for those who go on to develop side effects from immunotherapy.\n* Identify the molecular features associated with response and resistance to cancer therapies and immunotherapy using integrative genomic and immune repertoire characterization.\n* Capture and characterize systemic tumor burden by minimally invasive analyses of circulating tumor DNA.\n\nParticipants may be asked to:\n\n* Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue samples.\n* Complete questionnaires about immunotherapy side effects at baseline and with follow-up appointments.\n* Undergo knee x-rays.\n* Allow the use of demographic and clinical information.",[62,57,27],[241,242,243,244,245],"Upper Aerodigestive Malignancies","Upper Gastrointestinal (GI) Tract","Thorax","Immunobiology","Immunomodulatory",{"date":247,"type":38},"2026-08-06",{"date":249,"type":38},"2016-08-25",{"date":251,"type":21},"2028-08-25",{"name":253,"class":77},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":124,"phases":264,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":44},"100427519","phase-1-individual-response-to-hyperthermic-intraperitoneal-chemotherapy-hipec-treatment-of-peritoneal-carcinomatosis-from-peritoneal-mesothelioma-or-atypical-mesothelial-proliferation-or-from-ovarian-colorectal-or-appendiceal-histologies-100427519","NCT04847063","Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies","Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries","* INCLUSION CRITERIA:\n* Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI.\n* Measurable or evaluable disease as defined by RECIST v1.1. criteria and\u002For by peritoneal carcinomatosis index (PCI) score.\n* Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:\n\n  * Primary Histology: Appendiceal\u002FColorectal\u002FOvarian \u002F PCI Cutoff for Eligibility: Total Score \\\u003C 20 (out of 39 possible points)\n  * Primary Histology: Mesothelioma or atypical mesothelial proliferation \u002F PCI Cutoff for Eligibility: Total Score \\\u003C= 30 (out of 39 possible points)\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 1 (Karnofsky \\>= 80%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>= 1,000\u002FmcL\n  * Platelets \\>= 75,000\u002FmcL\n  * Total bilirubin within \\\u003C=1.5x institutional upper limit of normal (ULN)\n  * AST (SGOT)\u002F ALT (SGPT) \\\u003C= 3x institutional upper limit of normal (ULN), or \\\u003C= 5.0x ULN in participants with liver metastases (only)\n  * Creatinine within normal institutional limits\n\nOR\n\n--Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n\n* Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .\n\nEXCLUSION CRITERIA:\n\n* Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.\n* Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.\n* Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.\n* History of allergic reactions attributed to platinum-containing compounds.\n* History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).\n* HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.","120 Years",{"count":263,"type":21},60,[126],"Background:\n\nCytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve the results of CRS with HIPEC treatment on these tumors by choosing the chemotherapy drugs used in HIPEC.\n\nObjective:\n\nTo see if HIPEC after CRS can be improved, using either a model called the SMART (Sustained Microenvironment for Analysis of Resected Tissue) System or using 3-D cell culture (organoid) models, in order to test different chemotherapy drugs on tumors that were surgically removed prior to HIPEC treatment (these models are not attached to the body) versus tumors that were treated with HIPEC while still inside the body before being immediately surgically removed.\n\nEligibility:\n\nAdults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nElectrocardiogram (EKG)\n\nComputed tomography (CT) scan\n\nOther imaging scans, as needed\n\nTumor biopsy, if needed\n\nLaparoscopy (small cuts are made in the abdomen, and a tube with a light and a camera is used to see the organs in the abdomen), if needed\n\nParticipants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.\n\nSome screening tests may be repeated in the study.\n\nParticipants will have CRS. As many of their visible tumors will be removed as possible during surgery except for a few specific tumors left to receive the HIPEC treatment. Then they will receive HIPEC and the remaining tumors will be immediately removed. Participants will be in the hospital for 7-21 days after this surgery (CRS with HIPEC).\n\nParticipants will give tumor, fluid samples (from the abdomen during surgery), blood, saliva, cheek swab, and stool for research. They will complete surveys about their health and quality of life.\n\nParticipants with peritoneal mesothelioma (mesothelioma primary only) will have genetic (DNA) testing to determine clinical (CLIA level) germline BAP1 status for research use.\n\nParticipants will have follow-up visits for up to 5 years from CRS with HIPEC.\n\nIf there is disease progression, participants may have CRS with HIPEC again. Participants will then have follow-up visits for up to 5 years from the date of last CRS with HIPEC.",[267,268,269,27,270,271,94],"Peritoneal Mesothelioma","Peritoneal Carcinomatosis","Ovarian Cancer","Appendiceal Cancer","Atypical Mesothelial Proliferation",[273,274,275,276,277,278,279,280],"cytoreduction","organoid model","cell culture model","SMART System","Peritoneal Metastasis","necrosis","Ki-67","cytoreductive surgery (CRS)","2026-08-01",{"date":283,"type":38},"2026-08-04",{"date":285,"type":38},"2021-10-19",{"date":287,"type":21},"2034-12-30",{"name":42,"class":43},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":297,"studyType":22,"phases":4,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":306,"leadSponsor":308,"locationsCount":44},"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":296,"type":21},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.",[91,94,27],[94,91,301,302],"MDT","Artificial Intelligence","2026-07-31",{"date":219,"type":38},{"date":219,"type":21},{"date":307,"type":21},"2028-08-05",{"name":309,"class":77},"Shanghai Minimally Invasive Surgery Center",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":124,"phases":319,"briefSummary":320,"conditions":321,"keywords":326,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100550283","phase-1-study-of-rason-inhibitors-in-patients-with-gastrointestinal-solid-tumors-100550283","NCT06445062","Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","Inclusion Criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)\n* Presence of RAS G12D mutation (Subprotocol D, E, F)\n\nExclusion Criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery within 28 days of first dose\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":318,"type":21},1130,[126,127],"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.\n\nThe current subprotocols include the following:\n\nSubprotocol A: RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel\n\nSubprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel",[94,322,323,324,27,325],"CRC","Pancreatic Ductal Adenocarcinoma","PDAC","Metastatic Pancreatic Ductal Adenocarcinoma",[322,324,327,328,94,130,329,330,331,332,333],"RAS Mutation","KRAS G12X","Pancreatic Ductal Carcinoma","KRAS Q61 Mutation","KRAS G12 Mutation","RAS Wild-type","RAS G12D Mutation","2026-07-28",{"date":336,"type":38},"2026-07-29",{"date":338,"type":38},"2024-05-24",{"date":340,"type":21},"2027-07-15",{"name":342,"class":228},"Revolution Medicines, Inc.",32,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":124,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":4},"100648499","phase-2-butyrate-yogurt-for-cancer-constipation-100648499","NCT07723729","Butyrate Yogurt for Cancer Constipation","A Phase II Study on the Efficacy and Safety of Butyrate-Containing Short-Chain Fatty Acid Yogurt in Constipation in Patients With Gastrointestinal Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed diagnosis of gastrointestinal malignancy.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n4. Confirmed \\\u003C 3 spontaneous bowel movements (CSBM) per week during the 1-week baseline period, accompanied by constipation-related symptoms (e.g., straining, hard\u002Flumpy stools, sensation of incomplete evacuation, etc.).\n5. Anticancer treatment regimen is expected to remain relatively stable during the study period.\n6. Willing and able to provide written informed consent and complete electronic diary entries.\n\nExclusion Criteria:\n\n1. Mechanical intestinal obstruction, active inflammatory bowel disease, severe rectal stricture, or acute abdomen.\n2. Absolute neutrophil count (ANC) \\\u003C 1.0 × 10⁹\u002FL or active infection.\n3. New initiation or major dose adjustment of prosecretory or prokinetic agents within the past 2 weeks.\n4. Allergy or hypersensitivity to dairy products or any component of the butyrate-containing yogurt formulation.\n5. Deemed unsuitable for enrollment by the investigator (e.g., poor compliance, cognitive impairment, or other conditions that may interfere with study participation).",{"count":155,"type":21},[127],"Constipation is a common yet underrecognized supportive care issue in cancer patients. Its consequences extend beyond physical discomfort to include impaired quality of life, reduced opioid adherence leading to inadequate analgesia, and increased risks of fecal impaction, emergency visits, and hospitalization. Current management strategies-including laxatives, stool softeners, prokinetics, and PAMORAs-remain suboptimal due to limited effects on gut dysbiosis, mucosal barrier dysfunction, and chronic inflammation, as well as issues related to polypharmacy, variable efficacy, and long-term tolerability. Hence, there is a clear need for novel, well-tolerated, long-term interventions with nutritional benefits that target the gut microbiota-mucosal barrier-motility axis.\n\nShort-chain fatty acids (SCFAs), particularly butyrate, are key microbial metabolites that may improve constipation through multiple mechanisms: enhancing intestinal motility via enteric nervous system regulation, reinforcing mucosal barrier integrity and mitigating low-grade inflammation, and restoring gut microbial-metabolite homeostasis. Butyrate supplementation therefore holds mechanistic promise for cancer-related constipation.\n\nThe \"Small Blue Can High Dietary Fiber Butyrate SCFA Yogurt\" (Blueglass) is designed with a \"probiotics + prebiotics + acids\" synergistic fermentation platform, delivering ≥70 mg\u002F100 g butyrate combined with high dietary fiber. Compared with conventional laxatives or single-agent butyrate, this yogurt-based formulation offers potential advantages in patient acceptability, long-term adherence, dual exogenous and endogenous SCFA support, and multi-target action on motility, microbiome, and barrier function, making it a promising candidate for supportive care in this population.",[355,27],"Constipation","2026-07-20",{"date":358,"type":38},"2026-07-23",{"date":281,"type":21},{"date":361,"type":21},"2027-12-30",{"name":363,"class":77},"Tianjin Medical University Cancer Institute and Hospital",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":124,"phases":371,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":44},"100548377","goals-of-care-discussion-for-patients-with-advanced-lung-and-gastrointestinal-cancer-in-the-emergency-department-of-a-comprehensive-cancer-center-100548377","NCT06420206","Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center","Inclusion Criteria:\n\n1. Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment\n2. Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available.\n3. Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status)\n4. Participant has the ability to speak and write in English\n5. Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent\n\nExclusion Criteria:\n\n1. Participant is already enrolled in hospice\n2. Participant is comatose\n3. Participant has severe intellectual disability\n4. Participant has a history of dementia documented in the medical records\n5. Participant has baseline communication barriers such as aphasia or deafness\n6. Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival\n7. Participant is 18 years or older, currently cared for by pediatrics service\n8. Pregnant women\n9. Prisoners",{"count":87,"type":21},[372],"NA","To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.",[57,27],"2026-07-13",{"date":377,"type":38},"2026-07-14",{"date":379,"type":38},"2024-05-14",{"date":381,"type":21},"2027-02-02",{"name":383,"class":77},"M.D. Anderson Cancer Center",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":124,"phases":394,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":44},"100597306","phase-1-evaluation-of-the-preliminary-efficacy-and-safety-of-dr30206-in-combination-with-standard-therapy-in-patients-with-gastrointestinal-cancer-100597306","NCT07056777","Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer","A Phase Ib\u002FIIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Patients must be ≥ 18 and ≤75 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Expected survival period of at least 3 months.\n5. Depending on the tumor type, subjects must meet the following respective requirements:\n\n   1. Colorectal cancer: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer; ii. Subjects who have not previously received systemic chemotherapy(except for left-sided colorectal cancer with wild-type RAS\u002FBRAF); or subjects who have progressed after first-line chemotherapy with or without targeted or immunotherapy.\n   2. Other gastrointestinal tumors: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal adenocarcinoma, gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma, with HER2-negative or low expression; ii. Subjects who have not previously received systemic chemotherapy; for patients who previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease with curative intent, if disease progression occurs more than 6 months after the completion of the last treatment, they are eligible for this study.\n6. According to RECIST v1.1, subjects must have at least one measurable lesion.\n7. Adequate bone marrow, liver, and renal function.\n8. Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 180 days after the end of the last medication.\n9. Able to understand and follow the scheduled visits, treatments, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Subjects with MSI-H or dMMR.\n2. A history of severe allergic reactions to other monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to any investigational drug or its components in this study.\n3. Use of high-dose corticosteroids (\\>10 mg\u002Fday prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.\n4. Received the following treatments or medications within 28 days before starting the study treatment: a. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; b.Systemic treatment with anti-tumor drugs, or local anti-tumor therapy.\n5. Received local radiotherapy within 2 months prior to the first administration of investigational drug (palliative radiotherapy for bone metastasis completed more than 2 weeks before baseline tumor assessment is acceptable);\n6. Received non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first administration of investigational drug;\n7. Receipt of other investigational drugs or investigational medical devices within 28 days prior to the first administration of the investigational drug.\n8. Major surgery (defined as requiring general anesthesia and hospitalization for more than 24 hours) or severe traumatic injury within 28 days prior to the first administration of the investigational drug, or expected to require major surgery during the study period, except for minor procedures (e.g., tooth extraction, biopsy) deemed not to affect participation in the study by the investigator.\n9. Presence of severe chronic or active infections within 28 days prior to the first administration of the investigational drug, including but not limited to hospitalization for infection, sepsis, or severe pneumonia complications, or any active infection that the investigator considers may affect the participant's safety; or systemic antibiotic therapy within 2 weeks prior to the start of treatment (routine prophylactic anti-infective therapy is exempt).\n10. Persistent clinically significant toxicities (CTCAE 5.0 Grade 2 or higher, e.g., hyperpigmentation, alopecia, etc.), except for adverse reactions deemed to have no safety risk by the investigator, related to prior treatments (including systemic therapy, radiotherapy, or surgery).\n11. Presence of central nervous system (CNS) metastases and\u002For cancerous meningitis. Subjects who have received local treatment for brain metastases may be considered for participation in this study provided that imaging confirms no disease progression within 4 weeks prior to the first administration of the investigational drug, all neurological symptoms are stable, there is no evidence of new or enlarging CNS metastases, and radiotherapy, surgery, or corticosteroid therapy for CNS metastases has been discontinued for at least 28 days prior to the first administration of the investigational drug. However, cancerous meningitis, regardless of clinical stability, should be excluded.\n12. Hepatitis B virus infection (must meet both HBsAg positive and HBV-DNA \\> 500 IU\u002FmL), Hepatitis C virus infection (must meet both HCV-Ab positive and HCV-RNA positive), Human Immunodeficiency virus infection (HIV-Ab positive), active syphilis infection, active tuberculosis infection.\n13. There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing.\n14. Within 2 years prior to the first administration of the investigational drug, the subject has active autoimmune diseases requiring systemic treatment (e.g., use of glucocorticoids or immunosuppressive drugs). Replacement therapies (e.g., levothyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.\n15. Within 3 years prior to the first administration of the investigational drug, the subject has a history of other malignancies, except those cured by definitive treatment with expectation of cure, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any in situ cancer treated by definitive resection (e.g., cervical intraepithelial neoplasia, ductal carcinoma in situ).\n16. The subjects have other severe or uncontrolled medical conditions, or the investigator deems the subject unsuitable for participation in this clinical trial or believes it would affect the subject's adherence to the study protocol, including but not limited to: a) History of or current concomitant severe respiratory diseases; b) Severe arterial or venous thromboembolic events within 6 months prior to the first investigational drug administration; c) Massive pleural effusion, ascites, or pericardial effusion with clinical symptoms or requiring symptomatic treatment within 28 days prior to the first investigational drug administration; d) Active or history of inflammatory bowel disease; e) History of severe peptic ulcer, gastrointestinal perforation, fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, or esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first investigational drug administration; f) History of clinically significant bleeding symptoms within 1 month prior to the first study drug administration; g) Imaging at screening shows tumor encasement of major vessels or presence of significant necrosis or cavitation, and the investigator judges that enrollment would increase the risk of bleeding.\n17. The subject has a history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n18. The subject has a history of substance abuse or a mental disorder that may affect compliance with the study.\n19. Pregnant or breastfeeding women, where pregnancy is defined as the period from conception until the termination of pregnancy, and confirmed by a laboratory human chorionic gonadotropin (hCG) test within 7 days prior to the start of the study.\n20. Other conditions deemed unsuitable for participation in this study by the investigator.","75 Years",{"count":393,"type":21},186,[126,127],"This is a multicenter, open-label phase Ib\u002FIIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.",[27],[27],"2026-06-27",{"date":400,"type":38},"2026-06-30",{"date":402,"type":38},"2025-03-25",{"date":404,"type":21},"2027-06-30",{"name":406,"class":228},"Zhejiang Doer Biologics Co., Ltd.",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":414,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":124,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":44},"100464108","improving-comprehensive-care-of-cancer-patients-100464108","NCT05323409","Improving Comprehensive Care of Cancer Patients","Optimise: Improving Comprehensive Care of Cancer Patients With Comorbidities","Inclusion Criteria:\n\n* For patients: 1) new diagnosis or within three months of treatment initiation for early-stage breast (I-IIIB), GI (Stage I-III), or hematologic (Stage I-III) cancer 2) treatment with standard, definitive therapies (may include one or more modalities) 3) presence of one or more chronic comorbidities (e.g., diabetes, hypertension) and\u002For unhealthy lifestyle behaviors (e.g., overweight\u002Fobesity, current smoker, alcohol use) that require ongoing management during cancer treatment 4) age \\>18 years 5) fluency in English or Spanish 6) ability to provide informed consent 7) assignment to a Harris Health oncologist and PCP who are willing to participate and will provide informed consent.\n\nFor healthcare providers: 1) Person is an oncologist or PCP who treats patients with breast, GI, or hematologic malignancies at Harris Health BT\u002FSmith Clinic\n\nExclusion Criteria:\n\n* For Patients: Significant cognitive impairment or Lack of capacity to consent For Providers: None",true,{"count":416,"type":21},340,[372],"Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates the delivery of quality cancer care. Medically underserved patients, who bear the highest burden of multiple chronic conditions, are at increased risk for poor outcomes during and after cancer treatment. Enhancing communication and collaboration between oncologists and primary care providers (PCPs) could improve health outcomes and care transitions for these patients, who often lack healthcare knowledge and access to supportive care.\n\nThis study evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care), in the largest safety-net healthcare system in Houston, Texas. Three hundred newly diagnosed breast, gastrointestinal, and hematological cancer patients being treated with curative intent and having comorbidities requiring ongoing management will be randomized to either OPTIMISE or Usual Medical Care (UMC). UMC patients will receive cancer treatment directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits based on national guidelines.\n\nOPTIMISE patients will: 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance, facilitated by structured communication and referral processes; 3) receive an SCP that incorporates comorbidity management; and 4) follow a risk-stratified shared care model where some routine oncologist follow-up visits are replaced by PCP visits. Aim 1a evaluates OPTIMISE's impact on patient chronic disease self-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores OPTIMISE's effects on healthcare use and patient unmet needs during and after treatment. Aim 2 examines OPTIMISE's impact on oncologist and PCP attitudes and care coordination. Aim 3 elucidates patient- and system-level factors influencing implementation outcomes. If effective, OPTIMISE could expand to other cancers and enhance care transitions in various medical settings.",[56,27,420],"Hematologic Cancer","2026-06-26",{"date":400,"type":38},{"date":424,"type":38},"2022-04-01",{"date":426,"type":21},"2027-06",{"name":428,"class":77},"Baylor College of Medicine",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":124,"phases":438,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":453},"100499917","phase-2-a-study-on-the-effects-of-exercise-on-side-effects-from-treatment-for-gastrointestinal-cancers-100499917","NCT05789485","A Study on the Effects of Exercise on Side Effects From Treatment for Gastrointestinal Cancers","Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers","Inclusion Criteria:\n\n* Aged ≥18 years\n* Diagnosed with colorectal or esophago\u002Fgastric solid tumors as defined by one of the following:\n\n  * Histological confirmation\n  * As per standard of care imaging\n* Scheduled to receive neoadjuvant chemotherapy or chemotherapy for newly diagnosed metastatic disease\n* Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report\n* Willingness to comply with all study-related procedures\n* Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire\n\nExclusion Criteria:\n\n* Enrollment onto any other lifestyle interventional investigational study, except interventions determined by the PI not to confound study outcomes\n* Receiving treatment for any other diagnosis of invasive cancer\n* Mental impairment leading to inability to cooperate\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation",{"count":437,"type":21},216,[127],"The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.",[27],[442,443],"Exercise","22-164","2026-06-17",{"date":446,"type":38},"2026-06-22",{"date":448,"type":38},"2023-04-28",{"date":450,"type":21},"2027-04-18",{"name":452,"class":77},"Memorial Sloan Kettering Cancer Center",8,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":414,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":124,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100642375","gutcheck-optimization-of-a-personalized-mobile-health-app-for-survivors-of-gastrointestinal-cancer-100642375","NCT07661017","GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer","Inclusion\n\nSurvivors of GI cancer are eligible if they are:\n\n* ≥18 years old\n* reside in or have received cancer care in Minnesota\n* own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).\n* are English-speaking\n* have received a GI cancer diagnosis (e.g., esophageal, gastric, colorectal, liver, pancreatic, etc)\n* At least 2 months post-cancer treatment\n\nInclusion criteria for oncology specialists (oncologists, advanced practice providers, nurses, dietitians, and patient navigators) include:\n\n* Have interacted with at least 1 cancer patient or survivor in the past month.\n* Have experience working with electronic health records (EHR).\n\nExclusion\n\n* Currently pregnant (Patient Study ONLY)\n* Pregnancy status may be self-reported by the participant.\n* Individuals who are postmenopausal, surgically sterile, or otherwise unable to become pregnant are not subject to this exclusion.\n* Active cancer or receiving treatment for another cancer.\n* Currently taking or has taken antibiotics in the last 3 months.\n* Diagnosis of inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis), and\u002For celiac disease.\n* Involuntary weight loss of 10% or more of usual body weight within 6 months, or involuntary loss of 5% or more of usual body weight in 1 month.\n\nOncology specialists' exclusion criteria include:\n\n* Unable to participate in an interview",{"count":87,"type":21},[372],"There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.",[464,465,466,467,27,468,469],"Gastrointestinal","Mobile Health","Gastrointestinal Symptoms","Gut Health","Survivorship","GI Cancer","2026-06-16",{"date":446,"type":38},{"date":473,"type":21},"2026-12",{"date":475,"type":21},"2030-06",{"name":477,"class":77},"Masonic Cancer Center, University of Minnesota",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":124,"phases":487,"briefSummary":488,"conditions":489,"keywords":497,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100641147","digitally-supported-prehabilitation-before-major-visceral-cancer-surgery-100641147","NCT07658313","Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery","From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery","P2R-OncoVis","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Clinical diagnosis requiring major surgery of the pancreas, liver, bile ducts, stomach, or esophagus with curative intent\n* Confirmed indication for surgery by the multidisciplinary tumor board\n* Medical stability and physician clearance to participate in a prehabilitation exercise program\n* Willingness and ability to attend center-based prehabilitation exercise sessions three times per week, or once per week with additional tele-prehabilitation if travel time exceeds 40 minutes one way\n* Willingness and ability to perform home-based physical activities\n* Sufficient German language proficiency and digital literacy\n* Access to a smartphone or tablet device with internet connection\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Physical disability or mental impairment preventing safe participation in the study\n* Health care medical power of attorney not permitting independent consent\n* Non-elective, emergency, or revision surgery\n* Acute medical condition contraindicating participation in a structured prehabilitation program",{"count":155,"type":21},[372],"Major visceral oncologic surgery is associated with high postoperative morbidity, prolonged hospitalization, delayed recovery, and reduced quality of life. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical fitness, malnutrition, sarcopenia, and psychological distress, all of which may negatively affect surgical outcomes and rehabilitation. Although prehabilitation has shown potential to improve functional capacity before surgery, structured prehabilitation pathways are currently not routinely implemented in Austria, and the feasibility of digitally supported perioperative care pathways remains insufficiently evaluated.\n\nThe aim of the Prehab2Rehab-OncoVis study is to evaluate the feasibility, acceptability, and safety of a multimodal, digitally supported prehabilitation intervention for patients undergoing major visceral oncologic surgery with curative intent. The study will additionally explore potential effects on clinical recovery, functional capacity, rehabilitation outcomes, and patient-reported outcomes across the perioperative pathway.\n\nPrehab2Rehab-OncoVis is designed as a prospective, single-arm feasibility cohort study conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation, coordinated by the Paracelsus Medical University in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the Prehab2Rehab consortium. Approximately 30 adult patients, with the possibility to include up to 50 participants if feasible, will be consecutively recruited.\n\nThe intervention consists of a four-week multimodal prehabilitation program combining supervised exercise training, promotion of physical activity, nutritional counseling, psycho-oncological distress screening, and health literacy support. Digital tools will support the intervention throughout the perioperative pathway, including the HERO application (Das Herz Reha-Informationstool) for patient education and health literacy, aktivplan as a digital exercise planner and training diary, and the CAATS telecommunication platform for remote supervision and tele-prehabilitation sessions where appropriate.\n\nThe exercise intervention includes supervised center-based sessions and, for participants with longer travel distances, a hybrid model combining center-based and tele-prehabilitation sessions. Nutritional counseling will follow current European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines and includes screening for malnutrition risk. Psycho-oncological distress screening will follow recommendations of the German Cancer Society and includes referral to supportive care when clinically indicated.\n\nParticipants will be assessed throughout the perioperative pathway, including at the beginning and end of prehabilitation (Prehabilitation Assessment 1 \\[PRE1\\] and Prehabilitation Assessment 2 \\[PRE2\\]), during hospitalization and rehabilitation, and at a three-month follow-up after surgery. Primary outcomes focus on feasibility, including recruitment and retention rates, adherence, fidelity, safety, data management feasibility, and acceptability and usability of the digital technologies. Secondary outcomes include clinical recovery indicators, postoperative complications, length of hospital and intensive care stay, functional independence, psychological well-being, quality of life, body composition, cardiorespiratory fitness, functional exercise capacity, and muscle strength.\n\nTo contextualize outcomes, two historical comparator cohorts will be used: a local hospital cohort of patients who previously underwent similar surgery without prehabilitation, and a national rehabilitation cohort derived from routine rehabilitation datasets matched for diagnosis, sex, and age.\n\nThe study is intended to generate feasibility data and preliminary estimates that may support the development of future adequately powered randomized controlled trials evaluating digitally supported prehabilitation and rehabilitation pathways in visceral oncologic surgery.",[490,491,492,493,27,130,494,495,496],"Gastrointestinal Neoplasms","Pancreatic Neoplasms","Liver Neoplasm","Oesophageal Cancer","Liver Cancer","Prehabilitation","Cancer Rehabilitation",[495,498,499,500,501,502,503,504,505,506],"Visceral Surgery","Oncology","Rehabilitation","Digital Health","Exercise Therapy","Teleprehabilitation","Cancer Surgery","Preoperative Care","Functional Recovery",{"date":508,"type":38},"2026-06-18",{"date":510,"type":21},"2026-06",{"date":512,"type":21},"2027-07",{"name":514,"class":77},"Ludwig Boltzmann Institute for Digital Health and Prevention",2,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":124,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":515},"100588091","bolster-learning-new-skills-to-thrive-100588091","NCT06936878","BOLSTER: Learning New Skills to Thrive","BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers","BOLSTER","Participant Inclusion Criteria:\n\n* Age ≥18 years\n* Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient\n* Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)\n* Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)\n* Plans to receive ongoing cancer treatment\n* Has a family caregiver or friend (hereafter designated family caregiver) willing to participate\n* Able to speak and read English or Spanish (self-report)\n* Are willing to be audio-recorded\n* Have the cognitive\u002Fphysical ability to participate in a 60-minute interview\n\nFamily or Caregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Identified by a patient (as defined above) as a family or friend who is involved in their care.\n* Willing to participate in study visits\n* Willing to be audio recorded\n\nParticipant Exclusion Criteria:\n\n* Has cognitive impairments (as determined by the patient's oncologist)\n* Planning to enroll in hospice\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n\nFamily or Caregiver Exclusion Criteria:\n\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners",{"count":525,"type":21},600,[372],"This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.",[27,59,529],"Advanced Cancer",[27,59,529,531,532],"Advanced Gastrointestinal Cancer","Advanced Gynecologic Cancer",{"date":508,"type":38},{"date":535,"type":38},"2025-05-12",{"date":537,"type":21},"2028-07-31",{"name":539,"class":77},"Dana-Farber Cancer Institute",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":124,"phases":549,"briefSummary":550,"conditions":551,"keywords":563,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":515},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":548,"type":21},134,[127],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[552,553,58,57,56,554,94,27,555,556,557,558,559,560,561,562],"Brain Cancer","Brain Metastases","HER2-positive Breast Cancer","SRS","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[552,553,58,57,56,554,94,27,555,556,564,558,559,560,561,562],"Whole brain radiation",{"date":444,"type":38},{"date":567,"type":38},"2021-09-15",{"date":569,"type":21},"2029-05",{"name":571,"class":77},"Brigham and Women's Hospital",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":580,"targetDuration":297,"studyType":22,"phases":4,"briefSummary":582,"conditions":583,"keywords":586,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":592,"leadSponsor":594,"locationsCount":44},"100641271","non-operative-management-and-following-immunotherapy-for-colorectal-cancer-and-other-gi-cancers-100641271","NCT07656740","Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers","Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)","NOMIC","Inclusion Criteria:\n\n1. Retrospective Cohort Inclusion Criteria\n\n   * Pathologically confirmed gastrointestinal malignancy determined as MSI-H\u002FdMMR or POLE mutation, and initially resectable.\n   * Completed prior immunotherapy.\n   * No evidence of distant metastasis.\n   * Managed with W\\&W, LE, endoscopic surgery, or radical operation after treatment.\n2. Prospective Cohort Inclusion Criteria\n\n   * Pathologically confirmed gastrointestinal malignancy determined as MSI-H\u002FdMMR or POLE mutation, and initially resectable.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n   * Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR\u002Fnear-cCR or Non-cCR (≤ ymrT2N0).\n   * No evidence of distant metastasis.\n   * Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).\n\nExclusion Criteria:\n\n* Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.\n* Serum creatinine \\> 1.5 times upper limit of normal (ULN).\n* History of pelvic radiation therapy.Inability to tolerate MRI examinations.\n* History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).\n* Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack \\[TIA\\], cerebral vascular accident \\[CVA\\]).\n* Prior receipt of other types of investigational anti-tumor therapies.\n* Pregnant or lactating women.\n* Concomitant diseases or mental health conditions that may interfere with study participation.",{"count":581,"type":21},50,"This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient\u002Fmicrosatellite instability-high (dMMR\u002FMSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a \"Watch \\& Wait\" (W\\&W) strategy, while those with near-cCR or non-cCR ($\\\\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD\u002FEMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.",[27,584,585],"Colorectal (Colon or Rectal) Cancer","Stomach (Gastric) Cancer",[587,588],"dMMR\u002FMSI-H","POLE-mutated","2026-06-15",{"date":508,"type":38},{"date":589,"type":21},{"date":593,"type":21},"2030-10-15",{"name":113,"class":77},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":621},"100278638","ontario-wide-cancer-targeted-nucleic-acid-evaluation-100278638","NCT02906943","Ontario-wide Cancer TArgeted Nucleic Acid Evaluation","OCTANE","Inclusion Criteria:\n\n1. Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy.\n2. All patients must have sufficient FFPE archived tumor tissue for molecular profiling.\n3. Patient must be ≥ 18 years old.\n4. Patient's ECOG performance status equal to 0 or 1.\n5. All patients must have a life expectancy of \\> 6 months.\n6. All patients must have adequate organ functions.\n7. All patients must have signed and dated an informed consent form.\n\nExclusion Criteria:\n\n1\\. Patients must not have received more than 2 lines of prior cytotoxic therapy for their recurrent\u002Fmetastatic disease, with the exception of Phase I trial candidates who will not be excluded if more than 2 lines of prior cytotoxic therapy have been received.",{"count":603,"type":21},10000,"Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.\n\nBiomarkers are specific characteristics of the cancer that may help provide prognostic information (e.g. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.\n\nThe study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, which may help their physicians to identify which clinical trials of new drug treatments may be most appropriate for the patient in the future and may also guide the use of approved treatments that may potentially benefit the patient.\n\nAnother goal of this study is to develop a province-wide registry of targeted gene sequencing testing results that will be made available to cancer researchers. Additional tumour tissue and blood samples collected from all study participants will also be stored in a biobank at the Ontario Institute for Cancer Research for future research.\n\nThe study will also look at linking data from this study to other health care databases to further collect information about the health care the patients received, including medical tests, clinic visits, or procedures both before and after participating in this study. Having more information about patient health to relate to the DNA sequences may provide new insights into cancer and its treatment.",[56,57,94,58,606,60,61,27,62,63,607],"Gynecological Cancer","Unknown Primary Cancer",[609,529,610,611,612],"Molecular Profiling","Advanced Solid Tumors","Phase I Clinical Trial Candidates","Next Generation Sequencing","2026-06-03",{"date":615,"type":38},"2026-06-05",{"date":617,"type":4},"2016-08",{"date":619,"type":21},"2027-08",{"name":76,"class":77},7,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":124,"phases":631,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100613208","phase-1-a-study-of-db-1324-in-advancedmetastatic-gastrointestinal-tumors-100613208","NCT07263594","A Study of DB-1324 in Advanced\u002FMetastatic Gastrointestinal Tumors","A Phase 1\u002F2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced\u002FMetastatic Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Pathologically documented advanced\u002Funresectable, or metastatic GI tumor.\n2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.\n7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.\n8. Has an adequate treatment washout period before Day 1 of Cycle 1.\n9. Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.\n10. Other protocol-defined Inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Prior treatment with CDH17 targeted therapy.\n2. Prior treatment with ADC with topoisomerase I inhibitor.\n3. Has chronic enteritis or inflammatory bowel disease. Or has clinically significant bleeding of GI tract or adjacent organs within 1 month prior to the first dose of study treatment. Or has clinically significant obstruction and\u002For perforation and\u002For fistulae (including prior GI fistula operation) of GI tract or adjacent tissues within 6 months prior to the first dose of study treatment.\n4. Uncontrolled or significant cardiovascular disease.\n5. Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment.\n6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, or has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n7. Have a lung-specific intercurrent clinically significant illness.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n9. Has clinically active brain metastases.\n10. Has unresolved toxicities from previous anticancer therapy.\n11. Other protocol-defined Exclusion criteria apply.",{"count":630,"type":21},127,[126,127],"This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.",[27],[635],"Gastrointestinal Tumors, DB-1324","2026-05-19",{"date":638,"type":38},"2026-05-22",{"date":640,"type":38},"2026-01-20",{"date":642,"type":21},"2028-12",{"name":644,"class":228},"DualityBio Inc.",9,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":124,"phases":653,"briefSummary":654,"conditions":655,"keywords":661,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":44},"100536304","equity-gi-a-prospective-study-to-enhance-quality-inclusivity-and-trial-participation-in-black-patients-with-gastrointestinal-cancer-100536304","NCT06263088","EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.","Inclusion Criteria:\n\n1. Adult ≥ 18 years old.\n2. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.\n3. Patient able and willing to comply with study procedures\n4. The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.\n\nExclusion Criteria:\n\n* NONE",{"count":87,"type":21},[372],"This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).\n\nThis study has 3 components as follows-\n\n1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.\n2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.\n3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational\u002Finformational material appropriate for participant's diagnosis.",[27,131,132,656,93,657,658,659,494,660],"Anal Cancer","Stomach Cancer","Appendix Cancer","Pancreas Cancer","Neuroendocrine Tumors",[98,662],"African Americans",{"date":638,"type":38},{"date":665,"type":38},"2024-12-01",{"date":667,"type":21},"2026-09-30",{"name":669,"class":77},"Case Comprehensive Cancer Center",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":124,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":687,"leadSponsor":689,"locationsCount":4},"100637990","eat-ing-enhancing-anticancer-treatment-safety-via-immunomodulatory-nutritional-support-in-advanced-gastrointestinal-cancers-100637990","NCT07590622","EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers","EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers: A Single-Center Randomized Trial","EAT-ING","Inclusion Criteria:\n\n1. Will to participate by providing written IC.\n2. Male or female aged 18 years or older.\n3. A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.\n4. Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.\n5. Availability to take ONS.\n6. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.\n7. An ECOG PS of 2 or less.\n8. Investigator's assessment of life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. Are under 18 years of age.\n2. Inability to sign an IC.\n3. Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;\n4. Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;\n5. Pregnancy or lactation.",{"count":679,"type":21},88,[372],"The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies in reducing the risk of post-operative complications and the length of stay of patients undergoing major cancer surgery.\n\nThe guidelines for the nutritional management of patients with cancer agree on the utility of nutritional support, whenever it is necessary, to improve clinical outcomes, and the efficacy and tolerability of treatments.\n\nTo our knowledge, this is among the first clinical trial specifically designed to evaluate the role of immunomodulants-enriched ONS in combination with nutritional counseling in reducing serious AEs rate in patients with advanced GI cancers undergoing systemic treatments.",[27],"2026-05-13",{"date":685,"type":38},"2026-05-15",{"date":510,"type":21},{"date":688,"type":21},"2031-06",{"name":690,"class":77},"IRCCS San Raffaele",{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":697,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":124,"phases":701,"briefSummary":702,"conditions":703,"keywords":704,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":717},"100639199","a-study-of-selective-internal-radiation-therapy-for-the-management-of-chemotherapy-induced-thrombocytopenia-with-splenomegaly-in-adult-subjects-with-gastrointestinal-cancer-100639199","NCT07575854","A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer","A Pilot Feasibility Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenomegaly in Adult Subjects With Gastrointestinal Cancer","SPLENIC-SIRT","Inclusion Criteria:\n\n* Written informed consent prior to performing any protocol-related procedures, including screening evaluations.\n* Adult aged 18 years or above.\n* Metastatic or non-metastatic gastrointestinal cancer (gastric, pancreatic, colorectal…) histologically proven.\n* Splenomegaly validated by Splenic volume greater than or equal to 275 mL on imaging associated with thrombocytopenia (3D volumetry)\n* Ongoing thrombocytopenia with serum platelet count ≤ 80.000 mm³ observed on 2 consecutive biological assessments performed at least 7 days apart and at the latest 1 month apart. The second biological assessments should be dated at the latest 3 days from enrolment.\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Life expectancy of greater than 6 months\n* Adequate organ function as defined by the following:\n\n  1. Absolute neutrophil count ≥ 1000\u002Fmm³\n  2. Hemoglobin ≥ 8.0 g\u002FdL\n  3. Creatinine \\\u003C 1.5 × ULN or creatinine clearance ≥ 40mL\u002Fmin (Cockcroft-Gault formula)\n  4. ALAT and ASAT ≤ 5 × ULN\n  5. Prothrombin Rate (PR) \\> 50 % (non-correctable\\*) and Activated Partial Thromboplastin time (APTT) \\\u003C 1,5 second (non-correctable \\*) \\* non-correctable coagulopathy is defined as persistent coagulation abnormalities that cannot be corrected, even with appropriate therapeutic interventions (e.g., coagulation factor concentrates, vitamin K, or other corrective treatments)\n* Women patient of childbearing potential or male patient must agree to have efficient birth control method from inform consent form signature to 3 months after Selective internal radiation therapy (SIRT) procedure.\n\nExclusion Criteria:\n\n* Serum platelet count ≤35 000\u002F mm³.\n* History of prior partial splenic embolization, splenectomy or any significant medical history affecting the spleen including medical history of proven cirrhosis with at least one episode of decompensation in the last 6 months from enrolment.\n* Any non-Chemotherapy-Induced Thrombocytopenia and\u002For Chemotherapy-Induced Thrombocytopenia without splenomegaly (as per example, but not limited to, thrombocytopenia related to bone marrow toxicity)\n* Use of any treatment known to increase platelet count 1 month prior to Baseline.\n* History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.\n* Contraindications to angiography and selective visceral catheterization (bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents).\n* Spleen anatomy and\u002For splenic arterials anatomy and\u002For technical constraints identified during screening test which does not allow safe and\u002For ability to deliver the planned target dose\u002Factivity of TheraSphere\n* Serum platelet count ≤35 000\u002F mm³.\n* History of prior partial splenic embolization, splenectomy or any significant medical history affecting the spleen including medical history of proven cirrhosis with at least one episode of decompensation in the last 6 months from enrolment.\n* Any non-Chemotherapy-Induced Thrombocytopenia and\u002For Chemotherapy-Induced Thrombocytopenia without splenomegaly (as per example, but not limited to, thrombocytopenia related to bone marrow toxicity)\n* Use of any treatment known to increase platelet count 1 month prior to Baseline.\n* History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.\n* Contraindications to angiography and selective visceral catheterization (bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents).\n* Spleen anatomy and\u002For splenic arterials anatomy and\u002For technical constraints identified during screening test which does not allow safe and\u002For ability to deliver the planned target dose\u002Factivity of TheraSphere\n* History of bleeding disorder attributed to another cause other than thrombocytopenia (e.g., thrombopathy, coagulation disorder, gastric bleeding related to portal hypertension etc..) within 2 months of enrolment and\u002For any active bleeding disorder.\n* Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, uncontrolled congestive heart failure or respiratory disease and any toxicity from a prior treatment incompatible with the performance of the procedure. Comorbidities or Investigator judgement of poor overall health status which may make the patient a poor candidate for locoregional treatment.\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from ICF signature to 3 months after SIRT.\n* Person not affiliated or not beneficiary of a social security scheme and\u002For\n* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:\n\n  * Pregnant, parturient, breast-feeding women\n  * Minors (see also inclusion criterion 1)\n  * Persons receiving psychiatric treatment\n  * Persons admitted to a health or social establishment for purposes other than research\n  * Person of full age under curatorship\n  * Adult subject to a mandate for future protection, a family authorization, or a guardianship measure\n* Any contraindications to perform standard spleen SIRT procedure (for example, but not limited to splenic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis; contraindications to vaccination, etc.)\n* Patients with persistent coagulation abnormalities in the following scenarios:\n\n  * Severe hepatic disease, where the production of coagulation factors is significantly impaired and cannot be corrected by standard treatments.\n  * Coagulopathy induced by anticoagulants (e.g., direct oral anticoagulants or warfarin), where correction is not possible due to treatment instability or poor response to antidotes.\n  * Severe hemostatic dysfunction, where correction is not achieved despite appropriate intervention to restore coagulation balance.\n* Patients with Tc-99m MAA splenic arterial perfusion scintigraphy shows:\n\n  * any extra splenic uptake that may not be corrected by angiographic techniques. Any visual extra-splenic uptake that cannot be corrected by angiographic techniques.\n  * lung shunt that could result in the delivery of a dose greater than 30 Gy to the lungs",{"count":700,"type":21},18,[372],"This is a prospective, interventional, open-label, single-arm, multicenter pilot study evaluating the safety, tolerability and maximum tolerated dose (MTD) of splenic Selective Internal Radiation Therapy (SIRT) using TheraSphere in adult patietns with gastrointestinal cancer and chemotherapy-induced thrombocytopenia with splenomegaly",[27],[705,706,707,708],"splenomegaly","chemotherapy-induced thromobocytopenia","Splenic Selective Internal Radiation Therapy","TheraSphere","2026-05-11",{"date":683,"type":38},{"date":712,"type":21},"2026-10-01",{"date":714,"type":21},"2029-04-01",{"name":716,"class":77},"Centre Georges Francois Leclerc",4]