[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University Cancer Hospital & Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":594},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,109,0,25,[9,46,83,107,131,150,170,198,218,238,263,285,310,335,356,384,401,421,439,460,481,508,529,546,569],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100531693","construction-and-clinical-translation-of-ace-targeted-nuclear-medicine-imaging-probe-100531693",false,"NCT06203119","Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe","Inclusion Criteria\n\n1. Age 18 to 75 years, inclusive; sex unrestricted.\n2. Patients with triple-negative breast cancer (TNBC) or suspected TNBC who are scheduled to undergo pathological tissue biopsy or surgical treatment for the tumor in the near future (within 2 months).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Estimated life expectancy of ≥12 weeks.\n5. Adequate hematologic, coagulation, hepatic, and renal function, defined as follows:\n\nWBC ≥4.0 × 10⁹\u002FL or neutrophil count ≥1.5 × 10⁹\u002FL; PLT ≥100 × 10⁹\u002FL; Hb ≥90 g\u002FL; PT or APTT ≤1.5 × the upper limit of normal (ULN); Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in patients with liver metastases; ALP ≤2.5 × ULN, or ≤4.5 × ULN in patients with bone or liver metastases; BUN ≤1.5 × ULN; Serum creatinine ≤1.5 × ULN. 6:Presence of at least one measurable target lesion according to RECIST version 1.1.\n\n7::Female participants must use effective contraceptive measures during the study period and for 6 months after completion of the study. Male participants must agree to use effective contraceptive measures during the study period and for 6 months after completion of the study.\n\n8:Ability to understand the study procedures, voluntarily sign the informed consent form (ICF), and demonstrate good compliance with study requirements.\n\n9:Baseline assessment established based on \\^18F-FDG PET\u002FCT findings. Exclusion Criteria\n\n1. Presence of any of the following conditions: brain metastases, except asymptomatic primary or metastatic brain tumors that do not require treatment; carcinomatous meningitis; myocardial infarction within 6 months prior to enrollment; unstable angina; high risk of uncontrolled arrhythmia; history of coronary artery bypass grafting; cerebrovascular accident within 6 months prior to enrollment; congestive heart failure (NYHA Class III-IV); pulmonary embolism; deep vein thrombosis; concurrent infection requiring intravenous antibiotic treatment within the previous 2 weeks; or receipt of immunosuppressive therapy following organ transplantation.\n2. Primary central nervous system tumors.\n3. HBV DNA ≥10⁴ copies\u002FmL or ≥2,000 IU\u002FmL.\n4. HCV RNA ≥1,000 copies\u002FmL.\n5. Positive HIV antibody or syphilis antibody test.\n6. History of acute or subacute intestinal obstruction or inflammatory bowel disease.\n7. Pregnancy, breastfeeding, or plans to become pregnant during the study period.\n8. Known allergy to the investigational drug or any of its excipients.\n9. History of substance abuse involving psychiatric medications that cannot be discontinued, or presence of a psychiatric disorder.\n10. Inability to lie flat for at least 30 minutes.\n11. Known allergy to any component of the imaging agents or antibodies used in the study.\n12. Inability to undergo PET\u002FCT imaging.\n13. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This prospective, single-center, open-label study aims to evaluate the safety, biodistribution, and tumor imaging characteristics of the novel ACE1-targeted PET radiotracer 68Ga-DOTA-BPP in patients with confirmed or suspected triple-negative breast cancer (TNBC). Participants will undergo \\^68Ga-DOTA-BPP PET\u002FCT and 18F-FDG PET\u002FCT. Visual and semiquantitative imaging analyses will be performed to assess tracer uptake in tumor lesions and normal organs. The relationship between \\^68Ga-DOTA-BPP uptake and ACE1 expression will also be explored in participants with available tumor tissue.",[27],"Cancer",[29,30,31,32],"PET\u002FCT","TNBC","68Ga labeling","diagnosis","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":37},"2024-03-06",{"date":41,"type":21},"2026-12-02",{"name":43,"class":44},"Peking University Cancer Hospital & Institute","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"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":55,"type":21},200,"3 Months","OBSERVATIONAL","The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers.\n\nPatients with actionable molecular biomarkers, including dMMR\u002FMSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled.\n\nAfter immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions.\n\nThe study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.",[60,61,62,63,64],"Gastrointestinal Cancer","Gastric Cancer","Gastroesophageal Junction Cancer","Esophageal Cancer","Colorectal Cancer",[66,67,68,69,70,71,72,73,74],"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":34,"type":37},{"date":79,"type":21},"2026-09-01",{"date":81,"type":21},"2031-09-01",{"name":43,"class":44},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":45},"100575132","phase-2-assessment-of-adebelizumab-combined-with-chemotherapy-in-concurrent-radiotherapy-versus-sequential-radiotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100575132","NCT06768307","Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.","Inclusion Criteria:\n\n* Age ≥18 years, no gender restrictions;\n* Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a\u002Fb\u002Fc) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor\u002Fnodule size too large to be included in a tolerable radiation therapy plan;\n* Participants have not received systemic treatment for extensive-stage SCLC;\n* No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);\n* ECOG performance status score of 0-2;\n* Life expectancy ≥3 months;\n* Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;\n* Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:\n\nHemoglobin (Hb) ≥90g\u002FL; Platelet (PLT) ≥100×10\\^9\u002FL; Neutrophil count (ANC) ≥1.5×10\\^9\u002FL; White blood cell count (WBC) ≥3.0×10\\^9\u002FL;\n\nLymphocyte ≥0.5×10\\^9\u002FL; b) Biochemistry:\n\nAlanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g\u002FdL;\n\nRenal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL\u002Fminute (using Cockcroft\u002FGault formula); c) Coagulation:\n\nActivated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase \\>1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;\n\n* Female participants of childbearing potential must have a negative serum HCG test within 72 hours before the first dose, not breastfeeding, and must use a medically recognized contraceptive method (such as intrauterine devices, birth control pills, or condoms) during the study treatment and for 2 months after the last dose of Adebrelimab or 6 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer); male participants with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 2 months after the last dose of Adebrelimab or 3 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer), and no sperm donation during the study.\n\nExclusion Criteria:\n\n* Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, CD137 agonists, or other T-cell targeted drugs.\n* Participants who have previously received chemoradiotherapy for limited-stage SCLC;\n* Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size \\\u003C1cm are allowed to be included);\n* Participants with multiple liver metastases (isolated liver metastasis participants with metastasis \\\u003C2cm can be included)\n* Participants with spinal cord compression;\n* Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose, or with a history of autoimmune diseases and expected recurrence. Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first dose; the use of physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) is allowed;\n* Participants who have had arterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;\n* Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) at screening (participants with active tuberculosis are not included);\n* Participants who have undergone major surgical treatment or significant traumatic injury within 28 days before the first dose;\n* Participants who have received or plan to receive preventive vaccines or live-attenuated vaccines within 4 weeks before the first dose;\n* Participants who have received other trial medications or participated in another interventional clinical study within 4 weeks before signing the ICF;\n* Participants with other malignancies that require active treatment within 5 years (except for those with a \\>90% 5-year survival rate such as fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, or in situ breast cancer);\n* Participants with any severe and\u002For uncontrolled diseases, including: a) Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg) participants; history of hypertensive crisis or hypertensive encephalopathy; b) Uncontrolled cardiac clinical symptoms or diseases such as ≥grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmias (including men QTc ≥450ms, women QTc ≥470ms), and ≥grade 2 congestive heart failure (New York Heart Association, NYHA classification), unstable angina, myocardial infarction within 24 weeks, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; c) Active or uncontrolled severe infections (≥CTC AE grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, unexplained fever \\>38.5℃ before the first dose. d) Liver cirrhosis, active hepatitis\\*; \\*Active hepatitis - Hepatitis B reference: HBsAg positive, exceeding the upper limit of normal (1000 copies\u002Fml or 500 IU\u002Fml); participants with past Hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HbsAg, and normal HBV DNA values detected during the screening period can be included; \\*Hepatitis C reference: HCV antibody positive, and HCV viral load exceeds the upper limit of normal\u002FHCV RNA or HCV Ab indicates acute or chronic infection; e) HIV positive or known Acquired Immune Deficiency Syndrome (AIDS); f) Urine routine suggests urinary protein ≥++, and confirmed 24-hour urinary protein quantification \\>1.0 g;\n* Participants with clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, and abdominal effusion requiring repeated drainage (such as once a month or more frequently) that cannot be controlled by tapping or other treatments;\n* Participants whose adverse events (except for alopecia) caused by previous treatments have not recovered to ≤CTCAE grade 1; other toxicities caused by previous antitumor treatments that are expected to be unresolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based treatments, are allowed to be included;\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Known history of drug abuse that cannot be quit, mental disorders, alcoholism, drug abuse, or substance abuse;\n* Known allergy to study drugs or excipients, known severe allergic reactions to any monoclonal antibody;\n* As judged by the investigator, there are factors that seriously endanger the safety of the participants or other factors that may lead to the forced termination.",{"count":91,"type":21},60,[93],"PHASE2","Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.",[96,71,97,98],"SCLC, Extensive Stage","Chemotherapy","Radiotherapy","2026-08-13",{"date":101,"type":37},"2026-08-17",{"date":103,"type":37},"2025-01-07",{"date":105,"type":21},"2028-01-31",{"name":43,"class":44},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":45},"100571407","mmp14mt1-mmp-targeting-bicyclic-peptide-probe-for-pet-imaging-in-solid-tumors-100571407","NCT06719856","MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors","Inclusion Criteria:\n\n1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;\n2. age ≥18 and ≤75 years old, male or female;\n3. ECOG score 0 or 1;\n4. expected survival time ≥6 months;\n5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;\n6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;\n7. patients recommended by clinicians to undergo PET\u002FCT examination for tumor staging;\n8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.\n2. Individuals known or suspected to be allergic to the investigational drug or any of its components.\n3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \\> 1.5 × 20 µmol\u002FL, or aspartate aminotransferase (AST) \\> 2.5 × 45 µmol\u002FL, or alanine aminotransferase (ALT) \\> 2.5 × 40 µmol\u002FL, or serum creatinine \\> 1.5 × 130 µmol\u002FL.\n4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.\n5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.",{"count":114,"type":21},30,"The objective of the study is to construct a noninvasive approach using 68Ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.",[117],"Solid Tumor",[119,120,121,122],"solid tumor","MMP14","MT1-MMP","PET imaging","2026-08-09",{"date":125,"type":37},"2026-08-11",{"date":127,"type":37},"2025-01-01",{"date":129,"type":21},"2026-12-31",{"name":43,"class":44},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100571036","establishment-and-clinical-transformation-of-adc-drug-efficacy-evaluation-system-for-breast-cancer-based-on-molecular-imaging-100571036","NCT06715020","Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging","Inclusion Criteria:\n\n1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);\n2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 \u002FL, PLT ≥ 100×109\u002FL, Hb≥ 90 g\u002FL; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;\n3. Patients with confirmed or suspected breast cancer;\n4. Expected survival ≥12 weeks;\n5. Good follow-up compliance;\n6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;\n7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.\n\nExclusion Criteria:\n\n1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Unable to obtain informed consent;\n5. Suffering from claustrophobia or other mental illness;\n6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;\n7. Other conditions deemed unsuitable for participation in the trial by the investigator.",{"count":91,"type":21},[139],"NA","The objective of the study is to construct a noninvasive approach 68Ga-TTP PET\u002FCT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.",[142],"Breast Cancer","2026-08-07",{"date":125,"type":37},{"date":146,"type":37},"2024-12-10",{"date":148,"type":21},"2026-12",{"name":43,"class":44},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":45},"100648686","phase-1-18f-grazy-02-petct-of-granzyme-b-expression-for-monitoring-immunotherapy-100648686","NCT07724535","18F-grazy-02 PET\u002FCT of Granzyme B Expression for Monitoring Immunotherapy","18F-grazy-02 PET\u002FCT of Granzyme B Expression for Monitoring Immunotherapy in Patients With Lymphoma or Solid Tumors","Inclusion Criteria:\n\n1. 18-75 years old;\n2. ECOG score 0 or 1 point;\n3. Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET\u002FCT imaging for tumor diagnosis or staging.\n\nExclusion Criteria:\n\n1. Pregnant or nursing;\n2. Severe hepatic or renal dysfunction;\n3. Low WBC (less than 3 x 10\\^9\u002FL);\n4. Unable to comply with the PET\u002FCT imaging procedures.",true,{"count":114,"type":21},[24,93],"This is an open-label PET\u002FCT study to investigate the safety and clinical monitoring value of 18F-grazy-02 in patients with lymphoma or solid tumors receiving immunotherapy, including immune checkpoint inhibition and CAR-T cell therapy.",[27],"2026-07-29",{"date":164,"type":37},"2026-07-31",{"date":166,"type":37},"2026-06-24",{"date":168,"type":21},"2028-12-31",{"name":43,"class":44},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":157,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":180,"conditions":181,"keywords":186,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100646360","development-and-validation-of-a-colorectal-cancer-diagnostic-model-100646360","NCT07692555","Development and Validation of a Colorectal Cancer Diagnostic Model","Development and Validation of a Colorectal Cancer Diagnostic Model: A Multicenter Study in China (CCDM-CN)","Inclusion Criteria:\n\n* Age between 18 and 80 years at the time of enrollment.\n* Already scheduled to undergo colonoscopy according to routine clinical care, physical examination, or screening pathways at a participating medical institution.\n* No prior history of colorectal cancer or advanced colorectal neoplasia.\n* No contraindications to colonoscopy (as determined by the treating physician).\n* Able to understand the study information and complete the colorectal cancer risk-factor questionnaire independently or with appropriate assistance.\n* Willing to provide informed consent for completion of the questionnaire and for collection of routine clinical colonoscopy, pathology, and related medical-record data.\n\nExclusion Criteria:\n\n* The baseline colorectal cancer risk-factor questionnaire is not completed, or considered invalid because of substantial missing or inconsistent information.\n* The scheduled index colonoscopy is cancelled, not performed, or not completed regardless of the underlying reason (e.g., inadequate bowel preparation).\n* Incomplete or unavailable colonoscopy or pathology data after the procedure.\n* Refusal or withdrawal of informed consent.","80 Years",{"count":179,"type":21},20000,"This is a multicenter, observational study designed to develop and validate a diagnostic model for colorectal cancer and advanced colorectal neoplasia among adults undergoing routine-care colonoscopy in the Chinese population.\n\nThe study will enroll adults aged 18 to 80 years who have already been scheduled or planned to undergo colonoscopy according to routine clinical care, physical examination, or screening pathways at participating medical institutions. The study will not invite, organize, require, or otherwise arrange colonoscopy for any participant. Colonoscopy, bowel preparation, anesthesia assessment, biopsy, pathology examination, and subsequent clinical management will be performed solely according to the existing clinical pathway of each participating institution.\n\nAfter informed consent, participants will be invited to complete a standardized electronic questionnaire before their scheduled colonoscopy. The questionnaire will collect self-reported information on demographic characteristics, lifestyle factors, environmental exposures, personal medical history, family history of colorectal cancer, prior colonoscopy history, and gastrointestinal symptoms. The study team will also abstract colonoscopy and pathology results from medical records. No additional biological specimens will be collected for research purposes.\n\nThe primary clinical outcome is prevalent colorectal advanced neoplasia, defined as colorectal cancer, advanced colorectal adenoma, or advanced colorectal serrated lesion identified through colonoscopy and associated pathology. Statistical and machine-learning approaches will be used to develop and validate diagnostic models. Model performance will be evaluated by discrimination, calibration, and clinical net benefit in internal validation and multicenter external validation.",[64,182,183,184,185],"Advanced Neoplasia","Prediction Models","Risk Stratification","Precision Screening",[187,188,185,184],"Colorectal cancer","Colorectal Advanced Neoplasia","2026-07-21",{"date":191,"type":37},"2026-07-23",{"date":193,"type":21},"2026-07-15",{"date":195,"type":21},"2029-07-01",{"name":43,"class":44},4,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":45},"100645518","phase-2-shr-a1904-in-advanced-colorectal-cancer-an-exploratory-study-100645518","NCT07700719","SHR-A1904 in Advanced Colorectal Cancer: an Exploratory Study","Inclusion Criteria:\n\n1. Age 18-75 years, male or female.\n2. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n3. Failure of at least second-line standard systemic therapy, and must have received oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who have received all three classes of chemotherapeutic agents in first-line therapy may be enrolled after first-line treatment failure. For subjects with dMMR\u002FMSI-H tumors, prior anti-PD-1\u002FPD-L1 antibody therapy must have failed.\n4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.\n6. Life expectancy ≥ 3 months.\n7. Adequate major organ and bone marrow function before first dose of study drug, meeting the following criteria:\n\n   1. Hematology (without transfusion, G-CSF or other medical support within 14 days before study drug administration): Hemoglobin ≥ 90 g\u002FL; Platelets (PLT) ≥ 100×10\\^9\u002FL; White blood cells (WBC) ≥ 3.5×10\\^9\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL.\n   2. Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (in case of liver metastases, AST\u002FALT ≤ 5×ULN is permitted).\n   3. Renal function: Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   4. Coagulation: International normalized ratio (INR) ≤ 1.5×ULN (or INR 2-3 for patients on stable long-term warfarin therapy), and activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5×ULN.\n8. Male patients and female patients of childbearing potential must agree to use adequate and effective contraception during the study and for 12 months after the last dose. Female patients must not be breastfeeding and must have a negative serum pregnancy test (β-hCG) within 7 days before the first dose.\n9. Willing to voluntarily participate in this study, sign informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Known history of hypersensitivity to any component of the investigational product.\n2. Received systemic anti-tumor therapy within 4 weeks before the start of study treatment. If prior anti-tumor therapy was small molecule targeted therapy, the interval between the end of that treatment and the first study treatment should be no less than 5 half-lives of the drug or 7 days, whichever is longer. If prior anti-tumor Chinese patent medicine was received, an interval of no less than 2 weeks between the end of that treatment and the first study treatment is allowed.\n3. Toxicities and\u002For complications from prior interventions have not recovered to NCI-CTCAE grade ≤1 or to the level specified in the inclusion\u002Fexclusion criteria (except for toxicities deemed by the investigator to be safely manageable, such as alopecia, grade ≤2 peripheral neuropathy, etc.).\n4. Currently participating in another clinical study, or the time from first study drug administration to the end of a previous clinical study (last dose) is less than 4 weeks or 5 half-lives of that study drug, whichever is shorter.\n5. Received treatment with strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n6. Major surgery within 28 days before the first dose of study treatment (major surgery refers to procedures requiring general anesthesia; at least 3 weeks of recovery time is required before study drug administration; tissue biopsy for diagnostic purposes is allowed).\n7. Presence of another active malignancy other than the primary tumor (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection). Patients with a history of prior malignancy (with disease cured for ≥2 years) may be enrolled.\n8. Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases. If local treatment has been received and the patient's neurological symptoms have been stable for at least 2 weeks before the first dose, without requiring corticosteroids or requiring ≤10 mg\u002Fday prednisone (or equivalent), then participation is allowed.\n9. Presence of serious complications of the primary tumor (e.g., perforation, obstruction, massive hemorrhage not manageable by medical therapy).\n10. Uncontrolled or moderate to massive pleural effusion or pericardial effusion; clinically symptomatic moderate or severe ascites (i.e., requiring therapeutic paracentesis or drainage within 2 weeks before study treatment; patients with a small amount of ascites on imaging without clinical symptoms may be enrolled).\n11. Uncontrolled hypertension or prior history of hypertensive crisis.\n12. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second- or third-degree atrioventricular block, etc. Occurrence of acute coronary syndrome, congestive heart failure (New York Heart Association \\[NYHA\\] functional class ≥II), aortic dissection, stroke, or other grade ≥3 cardiovascular or cerebrovascular events within 6 months before the first dose.\n13. Presence of any significant clinical or laboratory abnormality that, in the investigator's judgment, would affect safety evaluation, such as uncontrolled diabetes mellitus, chronic kidney disease, thyroid dysfunction, poorly controlled hypercholesterolemia despite medication, etc.\n14. Active pulmonary tuberculosis, or history of active pulmonary tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment status.\n15. History of interstitial lung disease, or imaging findings at screening suggestive of or cannot rule out interstitial lung disease; or other moderate to severe pulmonary diseases that significantly affect lung function.\n16. Subjects with active hepatitis B or active hepatitis C.\n17. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or history of organ transplantation.\n18. Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection of CTCAE grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose.\n19. Pregnant or breastfeeding women, or patients of childbearing potential (males or females with less than one year of amenorrhea) who are unwilling to use contraceptive measures.\n20. Any other condition that, in the investigator's judgment, would increase the risk of study participation, interfere with the study results, or make the subject unsuitable for this study.",{"count":205,"type":21},17,[93],"To evaluate the safety and efficacy of SHR-A1904 in the advanced colorectal cancer after failure of standard therapy",[209],"Colorectal Cancer Metastatic","2026-07-08",{"date":212,"type":37},"2026-07-14",{"date":214,"type":21},"2026-07-28",{"date":216,"type":21},"2028-04-28",{"name":43,"class":44},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100646423","phase-2-fosrolapitant-and-palonosetron-for-the-prevention-of-antibody-drug-conjugate-induced-nausea-and-vomiting-100646423","NCT07692451","Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting","A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n1. 18 years of age or older, of either gender\n2. Has a diagnosed malignant tumor\n3. has never been treated with ADCs and is to receive the first course of ADCs\n4. Predicted life expectancy of ≥ 3 months\n5. Has a performance status (ECOG scale) of 0 to 1\n6. Adequate bone marrow, kidney, and liver function\n7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment\n8. Able and willing to provide a written informed consent",{"count":226,"type":21},124,[93],"This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting",[230],"Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)","2026-07-03",{"date":233,"type":37},"2026-07-09",{"date":193,"type":21},{"date":236,"type":21},"2027-09-30",{"name":43,"class":44},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":246,"targetDuration":248,"studyType":57,"phases":4,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":262,"locationsCount":45},"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":247,"type":21},50,"3 Years","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.",[60,251,252],"Colorectal (Colon or Rectal) Cancer","Stomach (Gastric) Cancer",[254,255],"dMMR\u002FMSI-H","POLE-mutated","2026-06-15",{"date":258,"type":37},"2026-06-18",{"date":256,"type":21},{"date":261,"type":21},"2030-10-15",{"name":43,"class":44},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":4},"100642171","phase-2-precision-medicine-for-immunotherapy-resistant-advanced-esophageal-cancer-100642171","NCT07653451","Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer","Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors","ESCC-PT","Inclusion Criteria:\n\n1. Signed written informed consent from previous studies and age ≥18 years.\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).\n3. Locally advanced, unresectable, or metastatic ESCC that progressed on or after standard second-line or later therapy containing immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 antibodies, or bispecific antibodies).\n4. At least one measurable lesion per RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Anticipated life expectancy ≥12 weeks.\n7. Adequate organ and bone marrow function within 14 days prior to the first dose (without blood transfusion, EPO, G-CSF, or other hematologic supports), as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n   * Platelet count ≥100×109\u002FL\n   * Hemoglobin ≥9 g\u002FdL (or ≥5.6 mmol\u002FL)\n   * Serum albumin \\>30 g\u002FL\n   * Serum creatinine ≤1.5×ULN (Upper Limit of Normal) or calculated creatinine clearance ≥60 mL\u002Fmin (using the Cockcroft-Gault formula)\n   * Total bilirubin ≤1.5×ULN\n   * AST and ALT ≤2.5×ULN (≤5.0×ULN for patients with documented liver metastases, provided total bilirubin is within normal limits)\n   * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN, and activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN\n8. Female patients of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to the first dose. WOCBP and male patients with WOCBP partners must agree to use highly effective contraception from signing the informed consent throughout the treatment period and for at least 6 months after the last dose. (Highly effective methods include oral\u002Fimplanted hormonal contraceptives, intrauterine devices \\[IUDs\\], or barrier methods combined with spermicide. Postmenopausal women aged \\>50 years must have been amenorrheic for ≥12 months to be considered postmenopausal).\n9. Required washout periods prior to the first dose of study treatment are as follows:\n\n   * Systemic anticancer therapies (chemotherapy, targeted therapy, immunotherapy, biological therapy, or hormonal therapy) or participation in clinical trials: \\>4 weeks.\n   * Systemic small-molecule targeted therapies: \\>2 weeks or 5 half-lives (whichever is longer).\n   * Prior Chinese herbal medicine with anti-tumor activity: \\>2 weeks.\n   * Prior major surgery or radiotherapy: \\>4 weeks (palliative radiotherapy for bone metastases: \\>2 weeks).\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Currently receiving concurrent antitumor therapies (including chemotherapy, systemic therapy, immunotherapy, radiotherapy, or surgery) at the time of enrollment.\n2. History of other malignancies within the past 3 years (except for cured thyroid cancer, cervical carcinoma in situ, basal\u002Fsquamous cell skin cancer, or other cured localized tumors with disease-free survival \\>3 years).\n3. Adverse events (AEs) from prior antitumor therapies that have not resolved to baseline or Grade ≤1 (excluding alopecia, Grade 2 anemia, or irreversible, clinically insignificant, asymptomatic laboratory abnormalities).\n4. Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose, or not fully recovered from surgical procedures; or plans for surgery during the study period.\n5. Active peripheral neuropathy (PN) or neurotoxicity ≥ Grade 2, history of Grade 3 neurotoxicity\u002FPN, or prior permanent discontinuation of treatment due to neurotoxicity\u002FPN.\n6. Active pneumonitis\u002Finterstitial lung disease (ILD), history of pulmonary radiation within 12 months prior to the first dose, or clinically significant underlying pulmonary disease (e.g., chronic obstructive pulmonary disease).\n7. Symptomatic or active central nervous system (CNS) metastases requiring intervention (including steroid therapy with prednisone \\>10 mg\u002Fday or equivalents, or anticonvulsants) within 4 weeks prior to the first dose.\n8. Any other severe underlying medical condition, including but not limited to: uncontrolled diabetes, active infections, vaccination within 4 weeks, active peptic ulcer, uncontrolled epilepsy, cerebrovascular accident within 6 months, gastrointestinal bleeding within 3 months, or clinical signs of coagulopathy.\n9. Clinically significant cardiovascular disease, including:\n\n   * Left ventricular ejection fraction (LVEF) ≤50% or below the institutional lower limit of normal (LLN) determined by echocardiography (ECHO) or MUGA scan (if ECHO is unavailable).\n   * Heart failure classified as NYHA Class ≥III.\n   * Uncontrolled hypertension (systolic BP ≥150 mmHg and\u002For diastolic BP ≥95 mmHg despite optimal medical therapy).\n   * Prior or current cardiomyopathy.\n   * Unstable angina, or myocardial infarction within 6 months.\n   * Serious arrhythmia requiring medical intervention (excluding controlled atrial fibrillation or paroxysmal supraventricular tachycardia).\n10. QTc interval ≥450 ms for males, or ≥470 ms for females (using Fridericia's formula), or history of congenital long QT syndrome.\n11. Dyspnea due to advanced malignancy complications or other diseases, requiring continuous supplemental oxygen therapy at rest.\n12. Any other severe psychiatric, psychological, familial, or geographical conditions that, in the investigator's opinion, could interfere with study compliance, protocol execution, follow-up, or place the patient at high risk of treatment-related complications.\n13. History of HIV infection or positive HIV serology.\n14. Active viral hepatitis B or C (Note: Patients with HBV are eligible if HBV DNA is within the normal range\u002Fsuppressed on antivirals; patients with positive HCV antibody are eligible if HCV RNA is undetectable via PCR). Frequent viral load monitoring is mandatory.\n15. History of life-threatening allergies, known hypersensitivity to any study drug components, recombinant proteins, or excipients, or intolerance to EGFR antibodies or eribulin.\n16. Pregnant or lactating women.\n17. Any concurrent medical condition that, in the investigator's clinical judgment, could compromise protocol compliance.",{"count":272,"type":21},90,[93,274],"PHASE3","This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle \\[Q4W\\]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.",[277],"Esophageal Squamous Cell Carcinoma","2026-06-12",{"date":280,"type":37},"2026-06-17",{"date":282,"type":21},"2026-07-01",{"date":168,"type":21},{"name":43,"class":44},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":309,"locationsCount":4},"100643410","68ga-fapi-psma-pet-imaging-for-the-diagnosis-of-solid-tumors-100643410","NCT07639801","68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors","Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET\u002FCT for the Diagnosis and Staging of Solid Tumors","Inclusion Criteria:\n\n* Age 18-75 years\n\n  * Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer)\n  * Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months\n  * ECOG performance status of 0 or 1\n  * Expected survival of at least 12 weeks\n  * Adequate hematologic and organ function:\n  * White blood cell count ≥ 4.0 × 10\\^9\u002FL or neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Platelet count ≥ 100 × 10\\^9\u002FL\n  * Hemoglobin ≥ 90 g\u002FL\n  * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  * ALT\u002FAST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 × ULN\n  * At least one measurable lesion according to RECIST 1.1 criteria\n  * Ability to understand the study procedures and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction\n* Inability to remain in a supine position for approximately 30 minutes during PET\u002FCT scanning\n* Refusal or inability to participate in the clinical study\n* Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures\n* Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study",{"count":20,"type":21},[139],"This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection.\n\nIn this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET\u002FCT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET\u002FCT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.",[296,297,298,299,300,301,302],"Prostate Cancer","Hepatocellular Carcinoma","Ovarian Cancer","Solid Tumors","Endometrial Cancer","FAPI","PSMA","2026-06-06",{"date":305,"type":37},"2026-06-10",{"date":307,"type":21},"2026-06",{"date":129,"type":21},{"name":43,"class":44},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":248,"studyType":57,"phases":4,"briefSummary":320,"conditions":321,"keywords":326,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":334,"locationsCount":4},"100643076","safety-and-efficacy-of-nom-and-opfs-versus-ro-for-dmmrmsi-h-or-pole-mutated-gastrointestinal-cancers-100643076","NCT07642323","Safety and Efficacy of NOM and OPFS Versus RO for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers","Safety and Efficacy of Nonoperative Management (NOM) and Organ Preservation First Strategy (OPFS) Versus Radical Operation (RO) for dMMR\u002FMSI-H or POLE-Mutated Gastrointestinal Cancers: A Single-Center, Bidirectional Registry Study","NOR-MP","Inclusion Criteria:\n\n* Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer).\n* Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations.\n* Received neoadjuvant\u002Fconversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation.\n* For the Retrospective Cohort (Part 1): Patients treated between \\[Start Month\u002FYear\\] and \\[End Month\u002FYear\\] who completed evaluation and subsequent strategy (NOM\u002FOPFS or RO).\n* For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery.\n* Age ≥ 18 years at the time of diagnosis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Concurrently diagnosed with other active malignant tumors within the past 5 years.\n* Patients with proficient mismatch repair (pMMR) \u002F microsatellite stable (MSS) tumors, or wild-type POLE status.\n* Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM\u002FOPFS or radical operation).\n* Inability to undergo regular endoscopic, radiological (MRI\u002FCT), or clinical follow-up due to compliance or geographic reasons.\n* Refusal to sign the informed consent form (applicable to the prospective cohort).",{"count":319,"type":21},22,"Purpose:\n\nThe purpose of this study is to evaluate the safety and efficacy of Non-Operative Management (NOM) and Organ Preservation First Strategy (OPFS) compared with Radical Operation (RO) in patients with deficient mismatch repair\u002Fmicrosatellite instability-high (dMMR\u002FMSI-H) or POLE-mutated gastrointestinal cancers.\n\nBackground \\& Design:\n\nWith the remarkable efficacy of neoadjuvant immunotherapy in dMMR\u002FMSI-H or POLE-mutated gastrointestinal tumors, organ preservation has become a promising alternative to highly invasive surgeries. The NOR-MP trial is a single-center, bidirectional registry study consisting of two parts: a retrospective cohort study and a prospective observational registry.\n\nIntervention Group (NOM\u002FOPFS): Patients who achieve a clinical complete response (cCR) or near-cCR after neoadjuvant immunotherapy will undergo a \"Watch \\& Wait\" (W\\&W) strategy. Patients with near-cCR or non-cCR who are eligible for organ preservation will undergo local excision (LE) or endoscopic resection (including ESD or EMR).\n\nComparison Group (Radical Operation): Patients who undergo standard radical surgical resection after neoadjuvant immunotherapy.\n\nThe study aims to determine whether an organ-preserving approach can achieve comparable oncological outcomes and safety profiles while significantly improving patients' quality of life compared to radical surgery.",[322,323,324,325],"Gastrointestinal Cancers","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Anus",[327,187,328],"Gastrointestinal cancers","Gastric cancer",{"date":330,"type":37},"2026-06-11",{"date":193,"type":21},{"date":333,"type":21},"2030-01-15",{"name":43,"class":44},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":340,"conditions":344,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100637294","phase-2-firmonertinib-in-perioperative-treatment-of-resectable-stage-ii-iiib-egfr-mutated-lung-adenocarcinoma-100637294","NCT07622706","Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* 1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.\n\n  2.Male or female, aged \\>=18 years; 3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.\n\n  4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest\u002Fabdominal CT, brain CT\u002FMRI, bone scan, or PET\u002FCT), with lesions eligible for radical resection.\n\n  5.EGFR mutation-positive (19Del and\u002For L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.\n\n  6.At least one measurable lesion with a longest diameter \\>=10 mm on baseline CT scan (except lymph nodes, which must have a short-axis diameter \\>=15 mm), and suitable for accurate and repeated measurement.\n\n  7.ECOG performance status 0-1. 8. Female patients should take adequate and effective contraception, must not breastfeed, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to demonstrate infertility:\n  1. Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy.\n  2. For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal.\n  3. Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.\n\n  9\\. Male patients should be willing to use barrier contraception, i.e., condoms.\n\nExclusion Criteria:\n\n* 1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.\n\n  2.Presence of EGFR exon 20 insertion mutation detected by genetic testing. 3.Prior exposure to other antitumor therapies before enrollment. 4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).\n\n  5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.\n\n  6.The patient is pregnant or breastfeeding. 7.Use of strong CYP3A4 inhibitors within 7 days, or strong CYP3A4 inducers within 21 days prior to the first dose of study drug; use of traditional Chinese medicines or herbal preparations indicated for antitumor treatment, those with tumor adjuvant effects, or any other agents with known antitumor activity within 14 days prior to the first dose.\n\n  8.History of other malignancies or concurrent malignancies, except for those that have been definitively treated with curative intent and with no evidence of recurrence for at least 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or papillary thyroid carcinoma).\n\n  9.Patients with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for participation by the investigator. These include but are not limited to: uncontrolled hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active bleeding disorders; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV antibody positive), or human immunodeficiency virus (HIV) infection; as well as patients with active infections requiring intravenous treatment.\n\n  10.Patients with severe gastrointestinal dysfunction or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrolled nausea and vomiting, or a history of extensive gastrointestinal resection.\n\n  11\\. Meets any of the following cardiac assessment criteria: (1) Resting ECG corrected QT interval (QTc) \\>470 msec, with QTc corrected using the Fridericia formula (if the initial ECG shows QTc \\>470 ms, repeat the ECG twice and take the average of the three QTc results). (2) Any clinically significant abnormalities in heart rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or third-degree atrioventricular block, etc. (3) Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in first-degree relatives under 40 years old, or taking any concomitant medication known to prolong the QT interval that cannot be discontinued.\n\n  12\\. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical manifestations suspected to be interstitial lung disease.\n\n  13\\. Any of the following laboratory test results indicating insufficient bone marrow or organ reserve function: (1) Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; (2) Platelet count \\\u003C100×10\\^9\u002FL; (3) Hemoglobin \\\u003C90 g\u002FL; (4) Alanine aminotransferase (ALT) \\>2.5× upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) \\>2.5×ULN; (6) Total bilirubin \\>1.5×ULN or, in the case of Gilbert's syndrome (unconjugated hyperbilirubinemia), \\>3×ULN; (7) Creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (8) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT) \\>=1.5 times ULN; 14. Known or suspected allergy to pralsetinib or any other component of its formulation; 15. Other situations where the patient is unable to comply with study procedures, restrictions, or requirements, and the investigator considers that such patient should not or is unsuitable to participate in the study; 16. Patients currently or previously participating in any other anti-tumor clinical study.",{"count":91,"type":21},[93],[345,346,347],"NSCLC","EGFR Positive Non-small Cell Lung Cancer","Neoadjuvant Therapy","2026-05-28",{"date":350,"type":37},"2026-06-03",{"date":352,"type":21},"2026-05-30",{"date":354,"type":21},"2029-11-30",{"name":43,"class":44},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":364,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100638535","phase-4-abemaciclib-dose-escalation-in-early-high-risk-breast-cancer-adjuvant-therapy-100638535","NCT07599137","Abemaciclib Dose Escalation in Early High-Risk Breast Cancer Adjuvant Therapy","Study on the Safety and Efficacy of Abemaciclib Dose Escalation Strategy in Adjuvant Therapy for Early High-Risk Breast Cancer","ADES","Inclusion Criteria:\n\n* Aged ≥18 years;\n* Pathologically confirmed breast cancer with ER and\u002For PR positive, HER2 negative;\n* Completed radical mastectomy\u002Fradiacal breast surgery;\n* Plan to receive abemaciclib combined endocrine therapy for at least 12 weeks, with abemaciclib administered via a step-up dosing regimen;\n* ECOG performance status 0-1;\n* Adequate organ function meeting medication requirements (routine blood test, liver and renal function, and other indicators consistent with clinical medication safety criteria);\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Previous exposure to any CDK4\u002F6 inhibitor;\n* Active infection or severe infection requiring systemic anti-infective treatment;\n* Significant gastrointestinal diseases such as chronic diarrhea, inflammatory bowel disease, short bowel syndrome, which may affect drug absorption or increase the risk of diarrhea;\n* Significant baseline hepatic or renal dysfunction, or uncontrolled severe comorbidities judged by the investigator to affect safety or treatment adherence;\n* Pregnancy or lactation;\n* Any other condition deemed ineligible for enrollment by the investigator.","FEMALE",{"count":366,"type":21},86,[368],"PHASE4","Abemaciclib combined with endocrine therapy has become one of the important adjuvant treatment regimens for patients with HR+\u002FHER2- high-risk early breast cancer. However, adverse events such as diarrhea, fatigue, neutropenia and elevated liver enzymes are concentrated in the early stage of adjuvant therapy, which often lead to dose reduction, temporary drug interruption or even permanent discontinuation. This further affects treatment adherence, relative dose intensity (RDI) and treatment completion rate.\n\nFindings from the TRADE study suggest that a step-up dosing strategy, initiating at a lower dose followed by gradual titration to the standard dose, combined with standardized patient education and symptomatic management, may improve early treatment tolerance, reduce the burden of partial toxicities, and increase the likelihood of patients achieving and maintaining abemaciclib 150 mg twice daily. Based on the above evidence and clinical experience, step-up dosing has been adopted by some clinicians for real-world clinical practice.\n\nNevertheless, existing evidence is mainly derived from non-Chinese populations. There is still a lack of systematic real-world data on step-up dosing among Chinese breast cancer patients under routine outpatient management, including the early toxicity profile, dose escalation achievement rate at each stage, dose adjustment pathways (prolonged escalation, treatment pause or dose de-escalation), RDI distribution, correlation with quality of life, and baseline factors affecting treatment tolerance and dose target attainment. Therefore, it is necessary to conduct a real-world study focused on Chinese patients to fill the gap in local clinical evidence, and provide a basis for clinical pathway formulation, patient education, and subsequent multicenter validation studies.",[371],"HR+\u002FHER2- Breast Cancer",[373,374,375,376],"breast cancer","Abemaciclib","Dose Escalation","side effect","2026-05-19",{"date":379,"type":37},"2026-05-20",{"date":352,"type":21},{"date":382,"type":21},"2028-02-01",{"name":43,"class":44},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":4},"100638014","phase-2-iparomlimab-tolvorlimab-as-neoadjuvant-immunotherapy-for-locally-advanced-gastric-adenocarcinoma-with-microsatellite-instabilitymismatch-repair-deficiency-100638014","NCT07595523","Iparomlimab Tolvorlimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma With Microsatellite Instability\u002FMismatch Repair Deficiency","Prospective, Single-Arm, Single-Center Phase II Clinical Study of Iparomlimab Tolvorlimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma With Microsatellite Instability\u002FMismatch Repair Deficiency","Inclusion Criteria:\n\n1. The subject voluntarily enrolls in this study, is able to provide signed informed consent, and has good compliance.\n2. Aged 18 to 75 years (at the time of signing informed consent), male or female.\n3. Histologically confirmed gastric adenocarcinoma, clinically staged as Stage II-III (locally advanced) per AJCC 8th edition based on endoscopic ultrasound or contrast-enhanced CT\u002FMRI scan. The subject agrees to undergo radical resection, and the lesion is assessed as resectable by the investigator. No prior systemic therapy for the current disease, including anti-tumor chemotherapy, radiotherapy, or immunotherapy.\n4. Tumor biopsy demonstrates dMMR status and concurrently meets the criteria for MSI-H.\n5. ECOG performance status score of 0 to 1.\n6. Expected survival ≥ 6 months.\n7. Adequate major organ function, meeting the following criteria: a) Routine blood test (without blood transfusion or hematopoietic stimulating agents within 14 days): Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelets (PLT) ≥ 100 × 10⁹\u002FL; b) Blood biochemistry: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; Total Bilirubin (TBIL) ≤ 1.5 × ULN; Serum Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤ 1.5 × ULN; c) Doppler echocardiography: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n8. Subjects of reproductive potential must use an effective contraceptive method during the study and for 120 days after study completion. Female subjects must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. History of other malignant diseases other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radically resected carcinoma in situ, and papillary thyroid carcinoma curable by local treatment).\n2. Currently participating in an interventional clinical study, or having received other investigational medicinal products or investigational device therapy within 4 weeks prior to the first dose.\n3. Received systemic therapy with Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n4. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.\n5. Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.Note: Physiological doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) are permitted.\n6. History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n7. Known hypersensitivity to any study drug used in this study.\n8. Peripheral neuropathy ≥ Grade 2.\n9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1\u002F2 antibody).\n10. Received live vaccine within 30 days prior to the first dose (Day 1 of Cycle 1). Note: Inactivated seasonal influenza vaccine by injection within 30 days prior to the first dose is permitted; however, live attenuated influenza vaccine administered intranasally is not permitted.\n11. Pregnant or lactating female subjects.\n12. Presence of any severe or uncontrolled systemic disease, such as: a) Significant and symptomatic uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting ECG; b) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA class ≥ 2; c) Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; d) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease; e) Active pulmonary tuberculosis; f) Active or uncontrolled infection requiring systemic therapy; g) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; h) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; i) Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein \\> 1.0 g; j) Mental disorders that prevent cooperation with study treatment.\n13. Presence of medical history, abnormal findings, or laboratory abnormalities that may interfere with study results or prevent the subject from completing the study; or any other conditions deemed by the investigator to be inappropriate for enrollment or to pose other potential risks.",{"count":114,"type":21},[93],"Study Background\n\n1. Clinical Rationale and Unmet Medical Need Gastric cancer is the 5th most common malignancy and the 3rd leading cause of cancer death worldwide. China accounts for \\>40% of global new cases, with nearly 90% of patients diagnosed at locally advanced stages and a 5-year overall survival (OS) rate of only 10%-49%. East Asia alone represents 58% of the global gastric cancer burden, with China reporting approximately 400,000 new cases and high mortality annually.\n\n   Although D2 radical gastrectomy remains the standard surgical treatment, local recurrence rates after surgery alone range from 24% to 54%, with most recurrences occurring within 2 years. Neoadjuvant chemotherapy is recommended by NCCN, ESMO, JGCA, and CSCO guidelines for locally advanced gastric cancer. However, the microsatellite instability-high\u002Fmismatch repair-deficient (dMMR\u002FMSI-H) subtype demonstrates poor response to chemotherapy but exceptional sensitivity to immunotherapy. Currently, no consensus exists on the optimal perioperative treatment for this population, and CSCO guidelines only recommend clinical trial participation or active surveillance.\n2. Immunotherapy Advances in dMMR\u002FMSI-H Gastric Cancer Immune checkpoint inhibitors (ICIs) targeting PD-1\u002FPD-L1 have revolutionized the treatment of dMMR\u002FMSI-H tumors by restoring anti-tumor immune responses. The phase II KEYNOTE-585 study (NCT03221426), the largest trial of neoadjuvant PD-1 monotherapy in this population, demonstrated a pathological complete response (pCR) rate of 32.8%, objective response rate (ORR) of 65.3%, and 3-year progression-free survival (PFS) rate of 78.5%-significantly superior to traditional chemotherapy (pCR 12.3%, 3-year PFS 52.1%). A phase II study of sintilimab monotherapy reported a pCR rate of 34.2%, major pathological response (MPR) rate of 52.2%, and grade ≥3 treatment-related adverse event (TRAE) rate of only 8.7%.\n\n   Dual immune checkpoint blockade further improves efficacy. The INFNITY study showed that neoadjuvant tremelimumab plus durvalumab achieved a pCR rate of 60% and MPR rate of 80% in 18 patients with resectable dMMR\u002FMSI-H gastric adenocarcinoma. These data confirm that immunotherapy, particularly dual checkpoint inhibition, offers superior efficacy and acceptable safety compared to chemotherapy in this patient subset.\n3. Study Agent: Apalimab\u002FTovorilimab (QL1706) Apalimab\u002FTovorilimab (QL1706) is a first-in-class bifunctional combination antibody developed using the MabPair® technology platform. It comprises anti-PD-1 antibody (apalimab) and anti-CTLA-4 antibody (tovorilimab) in a 2:1 molar ratio, simultaneously blocking both immune checkpoint pathways for synergistic anti-tumor activity.\n\n   Compared to separate administration of PD-1 and CTLA-4 inhibitors, QL1706 offers improved pharmacokinetics, enhanced targeting specificity, reduced off-target effects, lower TRAE rates, and simplified dosing (single infusion) that improves patient adherence. Clinical trials have demonstrated promising efficacy and safety across multiple tumor types:\n\n   Cervical cancer (DUBHE-C-206): ORR 33.8%, disease control rate (DCR) 64.9%, median PFS 5.4 months in platinum-refractory recurrent\u002Fmetastatic disease Hepatocellular carcinoma (DUBHE-H-308): ORR 40%, median PFS 8.1 months, 12-month OS rate 73.3% in combination with bevacizumab Non-small cell lung cancer (DUBHE-L-201): Median PFS 8.51 months, median OS 26.51 months, grade ≥3 TRAE rate 35.5% in combination with chemotherapy and bevacizumab\n4. Study Objectives and Significance This is a prospective, single-arm, single-center phase II clinical trial designed to evaluate the efficacy and safety of QL1706 as neoadjuvant therapy in patients with dMMR\u002FMSI-H locally advanced gastric adenocarcinoma. The primary objective is to assess the pCR rate, with secondary objectives including ORR, MPR rate, R0 resection rate, PFS, OS, and safety profile.\n\nThis study will provide critical clinical evidence for the use of QL1706 in the neoadjuvant setting. The results will: (1) establish a new treatment option for dMMR\u002FMSI-H gastric cancer patients; (2) lay the foundation for subsequent multicenter randomized phase III trials; (3) explore potential predictive biomarkers of response and resistance mechanisms; and (4) investigate the feasibility of surgery-sparing strategies for selected patients with exceptional response. Ultimately, this trial has the potential to transform the perioperative treatment paradigm for dMMR\u002FMSI-H gastric cancer and improve patient outcomes.",[61],"2026-05-18",{"date":379,"type":37},{"date":398,"type":21},"2026-06-01",{"date":195,"type":21},{"name":43,"class":44},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":45},"100637444","early-phase-1-clinical-application-of-caix-targeted-pet-imaging-in-tumors-100637444","NCT07590310","Clinical Application of CAIX-Targeted PET Imaging in Tumors","Inclusion Criteria:\n\n-Hematological, hepatic, and renal functions meeting the following criteria: Complete Blood Count: WBC ≥4.0×10⁹\u002FL or Neutrophils ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL; Coagulation: PT or APTT ≤1.5 × ULN (Upper Limit of Normal); Hepatic Function: T-Bil ≤1.5 × ULN; ALT\u002FAST ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastases); ALP ≤2.5 × ULN (or ≤4.5 × ULN for subjects with bone or liver metastases); Renal Function: BUN ≤1.5 × ULN, SCr ≤1.5 × ULN.\n\nNormal cardiac function;\n\n* Expected survival ≥12 weeks;\n* Good compliance with follow-up;\n* At least one measurable target lesion according to RECIST 1.1 criteria;\n* Women of childbearing potential (aged 18-49) must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of childbearing potential must agree to use effective contraception to prevent pregnancy during the study and for 3 months after the examination;\n* Patients for whom the clinician recommends a PET\u002FCT examination for tumor diagnosis and staging;\n* Patients are fully capable of understanding the study, voluntarily agree to participate, and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe abnormalities in hepatic, renal, or hematological function;\n* Patients planning for pregnancy;\n* Pregnant or lactating women;\n* Inability to lie flat for 30 minutes;\n* Refusal to participate in this clinical study;\n* Presence of claustrophobia or other psychiatric disorders;\n* Any other condition deemed unsuitable for participation by the investigator.",{"count":408,"type":21},3,[410],"EARLY_PHASE1","According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is crucial for improving prognosis. Nuclear medicine molecular imaging offers the advantages of real-time, dynamic, and non-invasive detection of lesions throughout the body. However, there is currently a lack of highly efficient and targeted molecular probes for early and accurate diagnosis of this tumor in clinical practice.\n\nThe high expression of CAIX plays a central role in the pathogenesis of renal cancer by altering cellular metabolism, inducing angiogenesis, promoting epithelial-mesenchymal transition (EMT), invasion, and metastatic spread. CAIX is highly expressed in 95% of ccRCC cases. In fact, CAIX expression levels have been reported as an independent predictor of survival in advanced ccRCC. Moreover, CAIX expression in normal tissues is limited, primarily restricted to the stomach, the basolateral aspects of proliferating small intestinal crypt epithelial cells, and the gallbladder. Therefore, the differential expression of CAIX between ccRCC tumors and normal tissues highlights its potential as a robust target for nuclear medicine molecular probe research and development in ccRCC.\n\nThis study utilized high-throughput screening to identify small molecules with high affinity for CAIX. These molecules were subsequently cyclized and modified to enhance their in vivo stability. A bifunctional chelator, H3RESCA, was introduced at the C-terminus to construct the small-molecule compound RESCA-CAIX-LT. PET probes were prepared by radiolabeling with 68Ga or 18F, and their diagnostic efficacy for renal cancer was investigated. Small-animal PET imaging initially demonstrated that the probe exhibits high affinity and excellent imaging performance. The modifications also altered the in vivo metabolic profile of the original design, reducing non-specific uptake in organs such as the stomach, small intestine, and gallbladder. Furthermore, toxicological experiments confirmed the probe's high safety profile and in vivo stability.",[413],"Kidney Cancers","2026-05-08",{"date":416,"type":37},"2026-05-15",{"date":418,"type":37},"2025-03-01",{"date":129,"type":21},{"name":43,"class":44},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":438,"locationsCount":45},"100637118","5t4-targeting-nanobody-probe-for-pet-imaging-in-solid-tumors-100637118","NCT07589101","5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors","Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer","Inclusion Criteria:\n\n1. Patients with solid tumors;\n2. Presence of measurable lesions on imaging examinations;\n3. Expected survival ≥12 weeks.\n\nExclusion Criteria:\n\n1. Severe hepatic or renal dysfunction;\n2. Women who are planning pregnancy, pregnant, or breastfeeding;\n3. Unable to remain in supine position for 30 minutes;\n4. Refusal to participate in this clinical study;\n5. Diagnosis of claustrophobia or other psychiatric disorders;\n6. Other conditions deemed by the investigator as inappropriate for participation in the trial.","70 Years",{"count":20,"type":21},[139],"This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors.\n\nThe 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread.\n\nIn this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET\u002FCT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET\u002FCT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.",[433,142],"Lung Cancer",{"date":416,"type":37},{"date":398,"type":21},{"date":437,"type":21},"2027-12-30",{"name":43,"class":44},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":457,"leadSponsor":459,"locationsCount":45},"100585994","al18f-her2-bch-pet-in-breast-patients-treated-with-adc-therapy-100585994","NCT06909604","Al18F-HER2-BCH PET in Breast Patients Treated With ADC Therapy","Al18F-HER2-BCH PET\u002FCT to Predict Response in Breast Patients Treated With ADC Therapy","FHERAD","Inclusion Criteria:\n\n1. Aged ≥18 years old; ECOG 0 or 1;\n2. Patients with HER2 positive or low tumors;\n3. Receives neoadjuvant therapy\n4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;\n5. Life expectancy \\> 3 months -\n\nExclusion Criteria:\n\n1. Significant hepatic or renal dysfunction;\n2. Is pregnant or ready to pregnant;\n3. Cannot keep their states for half an hour;\n4. Refused to join the clinical research;\n5. Suffering from claustrophobia or other mental disorders;\n6. Any other situation that researchers considered it unsuitable to participate in the trial.",{"count":247,"type":21},[139],"To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with ADC therapy",[142],[373,29,452,453],"HER2 expression","ADC therapy",{"date":455,"type":37},"2026-05-13",{"date":127,"type":37},{"date":458,"type":21},"2026-12-30",{"name":43,"class":44},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":4},"100636564","phase-2-adebrelimab-or-retlirafusp-alfa-plus-recaticimab-and-chemotherapy-for-resectable-nsclc-100636564","NCT07567326","Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC","A Phase II Study of Neoadjuvant Adebrelimab or Retlirafusp Alfa (SHR-1701) in Combination With Recaticimab and Chemotherapy for Resectable Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* 18-75 years old\n* Histologically or cytologically confirmed resectable stage II, IIIA, or selected IIIB (T2-3N2bM0 only) non-small cell lung cancer (NSCLC) according to the International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) 9th edition TNM classification for lung cancer, with the tumor judged by the investigator as amenable to curative-intent R0 resection.\n* Ability to provide tumor tissue specimens, either archived or freshly obtained prior to the first dose of study drug.\n* Presence of measurable target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST version 1.1. Tumor imaging assessment must be performed within 28 days before the first dose.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No prior anti-cancer therapy, including radiotherapy, chemotherapy, surgery, or targeted therapy, before study enrollment.\n* Adequate hematologic and end-organ function.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer (SCLC), mixed SCLC and NSCLC, or other non-NSCLC pathological types.\n* Known EGFR mutations or ALK positivity, or other actionable driver gene mutations for which approved targeted therapies are available and accessible.\n* Presence of malignant pleural effusion. For subjects with drainable pleural effusion during the screening period, at least one thoracentesis is required to rule out the presence of malignant cells.\n* Prior systemic anti-cancer therapy for non-small cell lung cancer. If the subject has previously received anti-cancer treatment with traditional Chinese medicine (TCM), enrollment is permitted only if the interval between the completion of TCM therapy and the first dose of study drug is at least 2 weeks.\n* Receipt of systemic immunosuppressive therapy within 2 weeks prior to the first dose, or expected need for systemic immunosuppressive medication during the study treatment period.\n* Current participation in an interventional clinical study treatment, or receipt of another investigational drug or investigational device within 4 weeks prior to the first dose.\n* History of malignancies other than NSCLC within 5 years prior to enrollment.\n* Presence of autoimmune disease.\n* Subjects with known or suspected interstitial lung disease; other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or significantly impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobstructive bronchiolitis, etc.\n* Subjects with severe cardiovascular or cerebrovascular diseases. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Arterial or venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.\n* Congenital or acquired immunodeficiency, including but not limited to human immunodeficiency virus (HIV) infection, active hepatitis B, or hepatitis C.\n* Evidence of active tuberculosis infection within 1 year prior to the first dose.\n* Severe infection within 4 weeks prior to the first dose.\n* Receipt of live attenuated vaccine within 28 days prior to the first dose, or planned receipt of live attenuated vaccine during the study period.\n* Major surgery (other than diagnostic procedures or biopsy) within 28 days prior to the first dose.\n* History of or planned allogeneic bone marrow transplantation or solid organ transplantation.\n* History of severe hypersensitivity reactions to other monoclonal antibodies or fusion proteins, or known allergy to any component of the randomly assigned treatment regimen.\n* Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n* Known history of substance abuse, alcohol abuse, or drug addiction.",{"count":468,"type":21},78,[93],"Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.",[472],"Non Small Cell Lung Cancer","2026-04-28",{"date":475,"type":37},"2026-05-05",{"date":477,"type":21},"2026-07",{"date":479,"type":21},"2030-12",{"name":43,"class":44},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":496,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":4},"100635401","comparison-of-68gaga-ctr-fapi-and-18f-fdg-petmri-for-lymph-node-staging-in-rectal-cancer-100635401","NCT07552207","Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET\u002FMRI for Lymph Node Staging in Rectal Cancer","Comparison of the Diagnostic Efficacy of [68Ga]Ga-CTR-FAPI PET\u002FMRI and 18F-FDG PET\u002FMRI for Lymph Node Metastasis in Middle to High Rectal Cancer","PKUCH-R12","Inclusion Criteria:\n\n* Confirmed rectal adenocarcinoma by pathological biopsy.\n* Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.\n* Planned to undergo radical surgery.\n* ECOG performance status score ≤ 2.\n* Patient is willing to undergo PET\u002FMRI examination.\n\nExclusion Criteria:\n\n* History of pelvic radiotherapy or chemotherapy.\n* Concurrent with other malignant tumors or active infections.\n* Pregnant or unable to sign the informed consent form.\n* Claustrophobia or inability to tolerate MRI examinations due to other reasons.",{"count":114,"type":21},[139],"This is a prospective, single-center, diagnostic study designed to compare the accuracy of \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI and \\[18\\]F-FDG PET\u002FMRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI provides higher sensitivity and specificity than traditional 18F-FDG PET\u002FMRI at both the patient level and the lymph node level.",[493,494,495],"Rectal Cancer","Lymph Node Metastases","PET \u002F MR",[497,498,499,500,501],"PET\u002FMR","[68Ga]Ga-CTR-FAPI","18F-FDG","Lymph Node Staging","Radiomics",{"date":503,"type":37},"2026-05-04",{"date":505,"type":21},"2026-04-01",{"date":168,"type":21},{"name":43,"class":44},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":4},"100633524","phase-2-optimization-of-dynamic-neoadjuvant-therapy-strategies-for-her2-positive-breast-cancer-based-on-her2-petct-molecular-imaging-100633524","NCT07527806","Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","Inclusion Criteria:\n\n* Voluntary participation with written informed consent obtained prior to any study-related procedures\n* Age ≥ 18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3\u002FcN0-2) breast cancer\n* Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present\n* Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive.\n* Adequate bone marrow, liver, and renal function: WBC \\> 3.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, Hb ≥ 10.0 g\u002FdL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST\u002FALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit.\n\nExclusion Criteria:\n\n* Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc\n* Locally advanced (cT4\u002FcN3) or bilateral breast cancer\n* Patients with known allergies to any active ingredients or excipients of investigational medicinal product\n* Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer\n* Left ventricular ejection fraction (LVEF) \\\u003C 55%\n* Uncontrolled hypertension (systolic \\> 150 mm Hg and\u002For diastolic \\> 100 mm Hg)\n* Severely cardiovascular disease\n* Current known infection with HIV, hepatitis B virus, or hepatitis C virus\n* Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent\n* Major surgical procedure or significant traumatic injury\n* Patient has other concurrent severe and\u002For uncontrolled medical conditions.\n* Concurrent participation in other interventional clinical trial\n* History of receiving any investigational treatment within 28 days prior to randomization\n* Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol\n* Inability to lie flat or presence of psychiatric disorders such as claustrophobia",{"count":516,"type":21},156,[93],"This study evaluates HER2-PET\u002FCT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.",[142],[373],"2026-04-14",{"date":523,"type":37},"2026-04-17",{"date":525,"type":21},"2026-05-01",{"date":527,"type":21},"2029-12-31",{"name":43,"class":44},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":16,"minAge":535,"maxAge":428,"enrollmentInfo":536,"targetDuration":537,"studyType":57,"phases":4,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":543,"leadSponsor":545,"locationsCount":45},"100633616","clinical-application-of-89zr-s-c1-petct-imaging-in-solid-tumors-100633616","NCT07529002","Clinical Application of 89Zr-s-C1 PET\u002FCT Imaging in Solid Tumors","Case inclusion criteria\n\n1. Patients with pathologically confirmed newly diagnosed solid tumors (such as melanoma, gastric cancer, colorectal cancer, etc.), or those with recent recurrence or suspected recurrence of previous solid tumors. Both male and female patients are eligible.\n2. Hematology, liver, and kidney function meeting the following criteria:\n\n   Hematology: WBC ≥ 4.0×10⁹\u002FL or neutrophil count ≥ 1.5×10⁹\u002FL, PLT ≥ 100×10⁹\u002FL, Hb ≥ 90 g\u002FL; PT or APTT ≤ 1.5 × ULN.\n\n   Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for subjects with liver metastases), ALP ≤ 2.5 × ULN (if bone or liver metastases are present, ALP ≤ 4.5 × ULN); BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN.\n3. Expected survival ≥ 12 weeks.\n4. Good compliance with follow-up.\n5. Presence of at least one measurable target lesion according to RECIST 1.1 criteria.\n6. Female subjects must use effective contraception (effective contraception refers to sterilization, intrauterine hormone devices, condoms, contraceptive pills\u002Fagents, abstinence, or vasectomized partner) during the study and for 6 months after the study ends; male subjects must agree to use contraception during the study and for 6 months after the study ends.\n7. Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form.\n\nCase exclusion criteria\n\n1. Severe liver and kidney dysfunction.\n2. Women preparing for pregnancy, pregnant, or breastfeeding.\n3. Inability to lie flat for half an hour.\n4. Inability to provide informed consent.\n5. Suffering from claustrophobia or other psychiatric disorders.\n6. Known allergy to the investigational drug or its excipients.\n7. Other situations deemed unsuitable for trial participation by the researchers.","15 Years",{"count":20,"type":21},"1 Year","This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET\u002FCT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.",[299],"2026-04-12",{"date":521,"type":37},{"date":521,"type":21},{"date":544,"type":21},"2028-03-01",{"name":43,"class":44},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":4},"100629096","pyrotinib-combined-with-trastuzumab-and-pertuzumab-for-maintenance-therapy-in-her2-positive-advanced-breast-cancer-100629096","NCT07470203","Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer","Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.\n3. Have unresectable locally advanced or metastatic disease. If recurrent (after \\[neo\\]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.\n4. Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.\n5. CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following: No evidence of brain metastases. Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n7. Have planned to receive maintenance anti-tumor therapy with pyrotinib in combination with HP\n8. Negative serum pregnancy test; women of childbearing potential must use a highly effective contraceptive method from study initiation until at least 6 months after the last dose of study medication.\n9. Voluntary participation with written informed consent obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Other malignancy diagnosed within 5 years prior to enrollment.\n2. Prior treatment with any tyrosine kinase inhibitor targeting HER2 and\u002For epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.\n3. Patients who are difficult or unable to be followed-up.\n4. Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.",{"count":554,"type":21},42,"This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.",[557],"HER2-positive Breast Cancer",[559,560],"pyrotinib","HER2-positive breast cancer","2026-03-09",{"date":563,"type":37},"2026-03-13",{"date":565,"type":21},"2026-03-31",{"date":567,"type":21},"2029-09-30",{"name":43,"class":44},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":576,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":4},"100626950","pd-l1-targeting-peptide-probe-for-pet-imaging-of-solid-tumor-100626950","NCT07442292","PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor","PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor","Inclusion Criteria:\n\n1. Aged 18-75, male and female, with ECOG score of 0 or 1;\n2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;\n3. underwent PD-L1 IHC examination before therapy;\n4. The expected survival was more than 26 weeks;\n5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \\>= 4.0 x 10\\^9\u002FL or neutrophil \\>= 1.5 x 10\\^9\u002F:, PLT \\>= 100 x 10\\^9 \u002F L, Hb \\>= 90g \u002F L; Pt or APTT \\\u003C= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \\\u003C= 1.5 x ULT (upper limit of normal value), ALT \u002F AST \\\u003C= 2.5 upper limit of normal value or \\\u003C= 5 x ULT (subject with liver metastasis), ALP \\\u003C= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \\\u003C= 4.5 upper limit of normal value); BUN \\\u003C= 1.5 x ULT, SCR \\\u003C= 1.5 x ULT;\n6. According to RECIST1.1, there was at least one measurable target lesion;\n7. Understand and sign informed consent voluntarily with good compliance.\n\nExclusion Criteria:\n\n1. The function of liver and kidney was seriously abnormal;\n2. Preparation for pregnant, pregnant and lactating women;\n3. Inability to lie flat for half an hour;\n4. Suffering from claustrophobia or other mental disorders;\n5. Other researchers considered it unsuitable to participate in the trial.",{"count":577,"type":21},40,"The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET\u002FCT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.",[580,581,582,583,584,585],"Lung Cancer (NSCLC)","Lung Cancer (SCLC)","Melanoma (Skin Cancer)","Melanoma Metastatic","PD-L1","PET \u002F CT","2026-03-03",{"date":588,"type":37},"2026-03-05",{"date":590,"type":21},"2026-02",{"date":592,"type":21},"2027-06",{"name":43,"class":44},""]