[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tao Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":178},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,66,87,109,133,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643072","phase-2-a-phase-ii-study-of-pirfenidone-plus-pd-1-inhibitor-with-or-without-hypofractionated-radiotherapy-for-refractory-pmmrmss-colorectal-cancer-100643072",false,"NCT07644286","A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR\u002FMSS Colorectal Cancer","Phase II Study Evaluating the Safety, Tolerability, and Efficacy of Pirfenidone and PD-1 Inhibitor With or Without Hypofractionated Radiotherapy in Patients With Advanced, Refractory pMMR\u002FMSS Colorectal Cancer","Inclusion Criteria:\n\n1. Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender.\n3. Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR\u002FMSS colorectal cancer.\n4. Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard therapy, or have refused standard therapy.\n5. Baseline\\* hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g\u002FL (without transfusion or erythropoietin support within 7 days prior to blood sampling).\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL (without granulocyte colony-stimulating factor support within 7 days prior to blood sampling).Platelet count ≥ 100 × 10⁹\u002FL (without transfusion support within 7 days prior to blood sampling).Eosinophil count ≤ 1.5 × ULN.\n\n9.Throughout the protocol, \"baseline\" is defined as the last available observation prior to the first dose of the study drug. Patients must not have received any blood products or hematopoietic growth factor support within 7 days prior to the blood sample collection.\n\n10.Baseline serum biochemistry tests (within 7 days prior to the first dose) must meet the following criteria:Total bilirubin ≤ 1.5 × ULN (if total bilirubin is \\>1.5 × ULN, direct bilirubin must be ≤ ULN for inclusion).Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 × ULN.\n\nSerum creatinine ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 45 mL\u002Fmin (using the Cockcroft-Gault formula and actual body weight).Albumin ≥ 30 g\u002FL.\n\n11.Baseline coagulation tests (within 7 days prior to the first dose) must meet the following criteria:International Normalized Ratio (INR) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).\n\n12.Baseline urinalysis (within 7 days prior to the first dose) must meet the following criterion: Urine Protein (UPRO) \\\u003C 2+ or 24-hour urinary protein quantification \\\u003C 1 g.\n\n13.At least one measurable lesion as defined by RECIST v1.1 criteria. 14.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 15.Life expectancy ≥ 3 months. 16.Male patients with partners of reproductive potential and female patients of childbearing potential must agree to use highly effective contraception throughout the treatment period and for 6 months thereafter.\n\nExclusion Criteria:\n\n1. All colorectal cancer patients must have confirmed MSS\u002FpMMR status; patients with MSI-H\u002FdMMR are excluded.\n2. History of hypersensitivity to any study drug components, including PD-1 inhibitors and pirfenidone.\n3. Female patients who are pregnant, lactating, or planning to become pregnant within 6 months after the last dose of the study drug.\n4. Known history or presence of active seizure disorder, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients with newly identified brain or leptomeningeal metastases are excluded.\n5. Significant cardiovascular or cerebrovascular diseases with clinical importance.\n6. History of allergic predisposition, asthma, or atopic dermatitis.\n7. Patients with massive pleural effusion or massive ascites.\n8. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years prior to the first dose. Replacement therapy is not considered systemic treatment.\n9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n10. Known or suspected hypersensitivity to the study drugs or any of their excipients.\n11. History of significant toxicity related to prior immune checkpoint inhibitor therapy or pirfenidone treatment that led to permanent discontinuation of the drug.\n12. Presence of unresolved \\> Grade 1 toxicities (except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, or hypomagnesemia) from any prior anticancer therapy.\n13. Active uncontrolled bleeding, known bleeding tendency, severe non-healing wounds, ulcers, fractures, or conditions such as esophageal\u002Fgastric varices requiring immediate intervention, or portal hypertension with high bleeding risk per investigator's assessment.\n14. History of intestinal obstruction (except if surgically cured or fully resolved) or risk of gastrointestinal perforation within 28 days prior to the first study dose.\n15. Current or recent (within 6 months) significant gastrointestinal disorders, including:\n\n    1. History of clinically significant GI bleeding,\n    2. Active peptic ulcer disease,\n    3. ≥ Grade 2 diarrhea within 2 weeks prior to the first study dose.\n16. Gastrointestinal diseases or prior surgeries that may affect the absorption of oral pirfenidone; uncontrolled tumor-related pain or symptomatic hypercalcemia.\n17. Known positive HIV status, active Hepatitis B, Hepatitis C, tuberculosis, or history of such infections. Exceptions include:\n\n    * Patients positive for HBsAg or HBcAb with HBV DNA ≤ 2.5×10³ copies\u002FmL or ≤ 500 IU\u002FmL or below the detection limit.\n    * Patients with positive HCV serology but undetectable HCV RNA.\n    * Patients who have received HCV treatment with undetectable viral load.\n18. Severe\u002Factive\u002Funcontrolled infection, infection requiring IV antibiotics, or unexplained fever (\\>38°C) within 2 weeks prior to the first study dose.\n19. Diagnosis of another malignancy within 5 years prior to the first dose, with exceptions for adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or localized prostate\u002Fthyroid cancer treated with curative intent.\n20. Prohibited treatments prior to enrollment:\n\n    * Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before the first study dose, with unresolved delayed toxicity.\n    * Monoclonal antibody therapy within 4 weeks prior to the first study dose.\n    * Participation in any interventional clinical trial involving medical devices or other therapies within 2 weeks prior to the first study dose.\n    * Palliative radiotherapy within 2 weeks prior to the first study dose.\n    * Live vaccines for infectious disease prevention within 4 weeks prior to the first study dose.\n    * Immunosuppressive or systemic steroid therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to the first study dose.\n    * Unstable anticoagulation control, thrombotic events, pulmonary embolism, or clinically significant bleeding within 6 months.\n    * Major surgery within 4 weeks prior to the first study dose.\n21. Any condition, therapy, laboratory abnormality, history of substance abuse, or current situation that may compromise patient safety, interfere with informed consent, affect compliance, or confound safety assessment of the study drug per investigator's judgment.\n22. Patients deemed unsuitable for clinical trial participation by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study aims to evaluate the safety, tolerability, and efficacy of pirfenidone and PD-1 monoclonal antibody combined with or without hypofractionated radiotherapy in the treatment of advanced refractory pMMR\u002FMSS colorectal cancer patients.",[27],"Colorectal Cancer (CRC)","RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":32},"2025-12-01",{"date":36,"type":21},"2027-12-25",{"name":38,"class":39},"Tao Zhang","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100601652","phase-3-a-clinical-trial-comparing-long-course-versus-short-course-radiotherapy-followed-by-immunotherapy-combined-with-total-neoadjuvant-therapy-tnt-to-long-course-radiotherapy-followed-by-tnt-in-locally-advanced-rectal-cancer-100601652","NCT07113275","A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. Immunohistochemistry and\u002For genetic testing confirmed pMMR\u002FMSS;\n5. inferior margin ≤ 10 cm from the anal verge;\n6. ECOG performance status score is 0-1;\n7. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n8. There was no operative contraindication;\n9. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count ≥ 100×109\u002FL; Hemoglobin ≥90 g\u002FL; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with MSI-H\u002FdMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).",{"count":49,"type":21},444,[51],"PHASE3","This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.",[54,55,56,57],"Rectal Cancer","Total Neoadjuvant Therapy","Radiotherapy","Immunotherapy","2026-05-10",{"date":60,"type":32},"2026-05-13",{"date":62,"type":21},"2026-05-15",{"date":64,"type":21},"2028-12-31",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100611352","phase-2-a-pilot-study-evaluating--hydroxybutyrate-supplementation-concomitant-to-short-course-radiotherapy-followed-by-immunotherapy-combined-with-capeox-neoadjuvant-therapy-in-patients-with-locally-advanced-rectal-cancer-100611352","NCT07239466","A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer","A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. inferior margin ≤ 10 cm from the anal verge;\n5. ECOG performance status score is 0-1;\n6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n7. There was no operative contraindication;\n8. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count ≥ 100×109\u002FL; Hemoglobin ≥90 g\u002FL; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n9. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with non-pMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).",{"count":74,"type":21},25,[24],"This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.",[54,56,57,78],"Chemotherapy","2026-04-20",{"date":81,"type":32},"2026-04-23",{"date":83,"type":32},"2026-01-01",{"date":85,"type":21},"2027-06-01",{"name":38,"class":39},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":40},"100620103","phase-2-phase-ibii-study-of-ql1706--fruquintinib--scrt-vs-standard-third-line-therapy-in-unresectable-liver-metastatic-pmmrmss-colorectal-cancer-safety-tolerability-and-efficacy-100620103","NCT07353268","Phase Ib\u002FII Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR\u002FMSS Colorectal Cancer: Safety, Tolerability, and Efficacy.","A Phase Ib\u002FII Study Evaluating the Safety, Tolerability, and Efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) and Fruquintinib Combined With Short-Course Radiotherapy (SCRT) Versus Standard Third-Line Therapy in Patients With Unresectable Liver-Metastatic pMMR\u002FMSS Colorectal Cancer.","Inclusion Criteria:\n\n1. Signed written informed consent, and ability to comply with the scheduled visits and related procedures as specified in the protocol.\n2. Age ≥18 years and ≤75 years, male or female.\n3. Histologically or cytologically confirmed metastatic colorectal cancer with unresectable liver metastasis(es) measuring ≥5 cm in the longest diameter.\n4. Confirmed pMMR (proficient mismatch repair) or MSS (microsatellite stable) status by immunohistochemistry (IHC), next-generation sequencing (NGS), or PCR testing.\n5. Disease progression after, intolerance to, lack of access to, or refusal of standard second-line therapy.\n6. Baseline\\* hematologic tests (within 7 days prior to the first dose of study drug) meeting the following criteria:\n\n   * Hemoglobin ≥90 g\u002FL.\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL.\n   * Platelet count ≥100 × 10⁹\u002FL.\n   * Eosinophil count ≤1.5 × Upper Limit of Normal (ULN).\n7. Baseline serum biochemical tests (within 7 days prior to the first dose) meeting the following criteria:\n\n   * Total bilirubin ≤1.5 × ULN (if total bilirubin \\>1.5 × ULN but direct bilirubin ≤ ULN, enrollment is permitted).\n   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3 × ULN.\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥45 mL\u002Fmin (calculated using the Cockcroft-Gault formula with actual body weight).\n   * Albumin ≥30 g\u002FL.\n8. Baseline coagulation tests (within 7 days prior to the first dose) meeting the following criteria:\n\n   * International normalized ratio (INR) ≤1.5 × ULN (or ≤3 × ULN if on stable-dose anticoagulation therapy).\n   * Partial thromboplastin time (PTT) \\[or activated partial thromboplastin time (aPTT)\\] ≤1.5 × ULN (or ≤3 × ULN if on stable-dose anticoagulation therapy).\n9. Baseline urinalysis (within 7 days prior to the first dose) meeting the following criterion: Urine protein (UPRO) \\\u003C2+ or 24-hour urine protein quantification \\\u003C1 g.\n10. At least one measurable lesion as defined by RECIST v1.1 criteria.\n11. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n12. Life expectancy ≥3 months.\n13. For female patients of childbearing potential or male patients with partners of childbearing potential, agreement to use effective contraception strictly throughout the treatment period and for 6 months thereafter.\n\nExclusion Criteria:\n\n* 1\\. History of allergy to any study drug, including Epalolitovoreli Monoclonal Antibody and Fruquintinib.\n\n  2\\. Pregnant or breastfeeding women, or women planning to become pregnant within 6 months before, during, or after the last dose of study drug.\n\n  3\\. Known history of active seizures, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases; newly diagnosed brain or leptomeningeal metastases.\n\n  4\\. Cardiovascular or cerebrovascular diseases with significant clinical implications, including:\n  * Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., antiarrhythmic medication).\n  * Severe conduction disorders (e.g., third-degree atrioventricular block).\n  * Heart rate-corrected QT interval (QTc, calculated using Fridericia's formula) ≥480 ms.\n  * Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.\n  * History of myocarditis.\n  * Current congestive heart failure requiring treatment.\n  * New York Heart Association (NYHA) Class III or IV cardiovascular disease.\n  * Acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to the first dose.\n  * Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.\n  * Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, radiation pneumonitis requiring steroid or other treatment, severe pulmonary dysfunction, or history of other forms of restrictive lung disease.\n\n    5\\. History of allergic constitution, asthma, or atopic dermatitis. 6. Patients with massive pleural effusion or massive ascites. 7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n\n    8\\. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n    9\\. Known or suspected hypersensitivity to the study drugs or any of their excipients.\n\n    10\\. History of significant toxicity related to immune checkpoint inhibitors or Fruquintinib-class drugs that led to permanent discontinuation of the treatment.\n\n    11\\. Residual toxicity \\> Grade 1 from any prior anti-tumor therapy (except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, and hypomagnesemia).\n\n    12\\. Active uncontrolled bleeding, known bleeding tendency, severely unhealed wounds, ulcers, or fractures; such as esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy); or evidence of portal hypertension deemed by the investigator to confer a high risk of bleeding.\n\n    13\\. Patients with risk of bowel obstruction (except surgically cured or completely resolved obstruction) or gastrointestinal perforation within 28 days prior to the first dose in this study (including, but not limited to, acute diverticulitis, intra-abdominal abscess, abdominal cancer, history of gastrointestinal perforation and\u002For fistula within 6 months prior to screening).\n\n    14\\. Patients with current or recent (within 6 months) significant gastrointestinal disease or conditions, including:\n\n    a) History of clinically significant gastrointestinal bleeding. b) Active peptic ulcer. c) Diarrhea ≥ Grade 2 within 2 weeks prior to the first dose. 15. Patients with uncontrolled tumor-related pain or symptomatic hypercalcemia. 16. Known positive HIV test, active Hepatitis B, Hepatitis C (HCV), tuberculosis, or history of such infections. Exceptions are as follows:\n  * Patients who are HBsAg positive or HBcAb positive must have HBV DNA ≤2.5 × 10³ copies\u002FmL or ≤500 IU\u002FmL or below the limit of detection to be eligible.\n  * Patients with positive HCV serology are eligible if HCV RNA is negative or below the limit of detection.\n  * Patients who have received HCV treatment and have undetectable viral loads are eligible.\n\n    17\\. Severe\u002Factive\u002Funcontrolled infection requiring systemic intravenous antibiotic therapy, or unexplained fever (\\>38°C) within 2 weeks prior to the first dose.\n\n    18\\. Diagnosis of another malignancy within 5 years prior to the first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, radically resected carcinoma in situ, radically treated localized prostate cancer, papillary thyroid carcinoma, etc.\n\n    19\\. Prohibited medications and other treatments (patients must not receive any of the following):\n  * Any chemotherapy or small molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, without delayed toxicity.\n  * Any monoclonal antibody therapy within 4 weeks prior to the first dose.\n  * Participation in any interventional clinical trial involving medical devices or other therapies within 2 weeks prior to the first dose.\n  * Palliative radiotherapy within 2 weeks prior to the first dose.\n  * Live vaccines for infectious disease prevention within 4 weeks prior to the first dose.\n  * Immunosuppressive or systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to the first dose.\n  * For patients on anticoagulant therapy, coagulation parameters are not stably controlled within the target range, or there is unstable thrombosis, pulmonary embolism events, or clinically significant bleeding events within the past 6 months.\n  * Any major surgery within 4 weeks prior to the first dose. 20. Any disease, treatment, laboratory abnormality, history of substance abuse, or current evidence that, in the investigator's judgment, may compromise the patient's safety, interfere with obtaining informed consent, affect patient compliance, or impact the safety evaluation of the study drug.\n\n    21\\. Patients deemed unsuitable for participation in this study by the investigator.",{"count":95,"type":21},76,[24],"This study is designed to evaluate the safety, tolerability, and efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) combined with Fruquintinib and Short-Course Radiotherapy (SCRT), compared with standard third-line therapy, in the treatment of patients with unresectable liver-metastatic pMMR\u002FMSS colorectal cancer.",[99],"Colorectal Cancer","NOT_YET_RECRUITING","2026-01-13",{"date":103,"type":32},"2026-01-20",{"date":105,"type":21},"2026-01-21",{"date":107,"type":21},"2027-12-31",{"name":38,"class":39},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100611696","phase-2-phase-ii-basket-trial-zanidatamab-plus-tislelizumab-in-her2-positive-gi-tumors-union-her2-basket-100611696","NCT07243938","Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)","A Prospective, Multi-cohort Clinical Study to Explore the Preliminary Efficacy and Safety of Zanidatamab in Combination With Tislelizumab for HER2-Positive GI Tumors: the UNION-HER2-BASKET Study","Inclusion Criteria:\n\n* Clinical diagnosis of gastric cancer and colorectal cancer\n* Aged 18 to 75 years:\n* Able to sign a written informed consent form and understand and comply with the requirements and evaluation schedule of this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* HER2-Positive: Immunohistochemistry (IHC) 3+ or IHC 2+ with FISH+ or NGS testing for high expression\n* Locally advanced rectal cancer cohort:\n\n  1. Histopathologically confirmed rectal adenocarcinoma\n  2. Tumor tissue confirmed by immunohistochemistry (IHC) as pMMR (high expression of MLH1, MSH2, MSH6, and PMS2 proteins), or confirmed by PCR or NGS as MSI-L or MSS\n  3. Tumor lower margin ≤10 cm from anal margin confirmed by colonoscopy, digital rectal examination, or MRI\n  4. Clinical stage cT3-4N0M0\u002FcTanyN+M0 (TNM staging per UICC\u002FAJCC 8th edition; T and N stages assessed by MRI)\n  5. Patients with one or more risk factors identified by MRI assessment: T4, tumor involvement of the mesorectal fascia (high MRF expression), extramural vascular invasion (high EMVI expression), ≥4 regional lymph node metastases (cN2), high lateral lymph node expression, or tumor margin ≤5 cm from the anal verge with strong organ preservation intent\n  6. No prior antitumor therapy for rectal cancer (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002Fformulated Chinese medicine treatment)\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n  2. Clinical stage III-IVa (i.e., TNM staging T3\\~4aN+M0 or T4bNanyM0, refer to UICC\u002FAJCC 8th edition)\n  3. No prior antitumor therapy for gastric or gastroesophageal junction adenocarcinoma (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002FChinese patent medicine treatment)\n* Advanced colorectal cancer cohort:\n\n  1. Histopathologically confirmed advanced colorectal cancer\n  2. Previous systemic anticancer therapy for metastatic colorectal cancer with documented failure, including fluoropyrimidine, oxaliplatin, irinotecan, cetuximab, or bevacizumab (excluding contraindications). Prior anti-HER2 therapy permitted\n  3. At least one measurable lesion defined according to RECIST 1.1\n  4. Expected survival \\> 3 months\n* Good organ function within ≤7 days prior to first study drug administration, as demonstrated by the following laboratory values:\n\n  1. No blood or platelet transfusions or growth factor support therapy within ≤14 days prior to blood sample collection during the screening period, and must meet:\n  2. ANC ≥ 1.5 x 10⁹\u002FL\n  3. Platelet count ≥ 100 x 10⁹\u002FL\n  4. Hemoglobin ≥ 90 g\u002FL\n  5. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN)\n  6. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)\n  7. Serum total bilirubin ≤ 1.5 times ULN (≤ 3 times ULN for patients with liver metastases)\n  8. International Normalized Ratio (INR) ≤ 1.5 or Prothrombin Time ≤ 1.5 times ULN\n  9. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN\n  10. Serum albumin ≥ 30 g\u002FL\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must be willing to use highly effective contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 120 days after the last dose.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible for inclusion in this study:\n\n* History of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ, provided complete remission was achieved at least 5 years prior to screening and no additional treatment is required or anticipated during the study period.\n* Any of the following cardiovascular criteria:\n\n  1. Cardiac chest pain occurring ≤28 days prior to the first study drug administration, defined as moderate pain limiting daily activities or exercise\n  2. Symptomatic pulmonary embolism within ≤28 days prior to the first dose of study drug\n  3. History of any acute myocardial infarction within ≤6 months prior to the first dose of study drug\n  4. History of any New York Heart Association (NYHA) Class III or IV heart failure within ≤6 months prior to the first dose of study drug\n  5. Any ventricular arrhythmia event of severity ≥ Grade 2 within ≤ 6 months prior to the first dose of the study drug\n  6. History of any cerebrovascular accident within ≤6 months prior to the first dose of the study drug\n  7. Corrected QT interval (QTc) (corrected using Fridericia's formula) ≥ 470 msec in females or ≥ 450 msec in males\n\n  i) Note: If any patient's initial ECG shows a QTc interval \\> 450 msec (male) or \\> 470 msec (female), a follow-up ECG will be performed to verify the result h) Left ventricular ejection fraction (LVEF) ≤50% as assessed by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO). Follow-up assessment must use the same modality as the baseline assessment\n* Any syncope or seizure occurring ≤28 days prior to the first study drug administration.\n* Active autoimmune disease requiring systemic treatment within the past 2 years.\n* Known history of human immunodeficiency virus (HIV) infection\n* Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \\> 500 IU\u002FmL) or active HCV carriers with detectable HCV RNA; Note: Inactive hepatitis B surface antigen (HBsAg) carriers and treated, stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL) are eligible for enrollment\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary conditions, including pulmonary fibrosis, acute pulmonary disease, etc.\n* Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first study drug dose. Note: Antiviral therapy is permitted for patients with viral hepatitis.\n* Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \\>10 mg\u002Fday) or other immunosuppressive agents within ≤14 days prior to the first dose of study drug\n* Hypersensitivity to any component of tislelizumab, zanidatamab，capecitabine, S-1, oxaliplatin, or any component of the container\n* Any major surgery requiring general anesthesia within ≤28 days prior to the first dose of study drug\n* Bleeding, thrombotic disorders, or use of anticoagulants (e.g., warfarin) or similar agents requiring therapeutic INR monitoring within 6 months prior to the first dose of study drug\n* History of allogeneic stem cell transplantation or organ transplantation\n* Live vaccine administration within ≤28 days prior to the first study drug dose. Note: Seasonal influenza vaccines, broadly classified as inactivated vaccines, are permitted. Inactivated COVID-19 vaccines are permitted. mRNA COVID-19 vaccines are not permitted. Intranasal influenza vaccines are live vaccines and are not permitted.\n* Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the participant is in the follow-up period of an interventional study\n* Inability to swallow tablets or diseases significantly affecting gastrointestinal function\n* Pregnant or lactating women\n* Other conditions deemed ineligible by the investigator.\n* Locally Advanced Rectal Cancer Cohort:\n\n  1. Previous treatment for rectal cancer, or clinical or imaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation with bleeding, prior abdominal abscess, or recent (within 3 months) occurrence of gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Assessed by the investigator as initially unresectable or unable to tolerate surgery\n  4. Patient assessed by the investigator as having factors rendering them unsuitable for radiotherapy\n  5. The patient has ≥2 concurrent colorectal cancer lesions\n  6. Patient has contraindications for MRI examination\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Previous treatment for gastric\u002Fgastroesophageal junction cancer, or clinical\u002Fimaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation, or bleeding; prior abdominal abscess; or recent (within 3 months) gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Initial inoperability as assessed by the investigator, or inability of the patient to tolerate surgery\n* Advanced colorectal cancer cohort:\n\n  1. Patients with any prior histopathological or hematological ctDNA testing demonstrating mismatch repair gene deficiency (dMMR) or microsatellite instability (MSI-H)\n  2. Presence of active leptomeningeal disease or uncontrolled brain metastases. Patients with previously treated brain metastases may be eligible if imaging shows stability, confirmed by repeat imaging demonstrating no progression for at least 4 weeks (Note: repeat imaging must occur during the study screening period).",{"count":117,"type":21},70,[24],"This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy\u002Fradiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.",[121,122,123,124],"Locally Advanced Rectal Cancer (LARC)","Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Metastatic Colorectal Cancer (mCRC)","Neoadjuvant Therapy","2025-11-21",{"date":127,"type":32},"2025-11-24",{"date":129,"type":21},"2026-01-15",{"date":131,"type":21},"2031-06-01",{"name":38,"class":39},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100553320","phase-1-t-cell-receptor-gene-engineered-t-cell-therapy-targeting-kras-mutations-in-the-treatment-of-subjects-with-advanced-solid-tumor-100553320","NCT06484556","T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","Key Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments\n* HLA-A\\*11:01positive\n* Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation\n* Adequate organ function prior to apheresis and lymphodepleting chemotherapy\n* ECOG performance status of 0-1\n* At least one tumor lesion measurable according to RECIST 1.1\n\n(Additional protocol-defined Inclusion criteria may apply.)\n\nKey Exclusion Criteria:\n\n* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\n* Have symptomic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Active infections with HIV, HBV, HCV, or syphilis\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Exclusion criteria may apply.)",{"count":141,"type":21},9,[143],"PHASE1","An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics\u002Fpharmacodynamic (PK\u002FPD) of NW-301V and NW-301D in subjects with advanced solid tumor.",[146],"Tumor, Solid","2025-07-27",{"date":149,"type":32},"2025-07-31",{"date":151,"type":32},"2024-06-19",{"date":153,"type":21},"2027-06-30",{"name":38,"class":39},2,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":40},"100592966","phase-2-a-study-of-cetuximab-combined-with-envolimab-and-mfolfox6-in-subjects-with-advanced-colorectal-cancer-100592966","NCT07000305","A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer","Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS\u002FBRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail","SUPβORT","Inclusion Criteria:\n\n1. have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.\n2. At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.\n3. Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.\n4. Advanced or metastatic colorectal cancer (AJCC\u002FUICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).\n5. no prior systemic therapy (including epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies) directed against advanced or metastatic colorectal cancer, but are allowed to receive a maximum of one cycle of the mFOLFOX6 regimen prior to enrollment ; Adjuvant\u002Fneoadjuvant therapy is considered a first-line systemic therapy for advanced or metastatic disease if recurrence or metastasis occurs during or within 6 months of completion of adjuvant or neoadjuvant chemotherapy.\n6. an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.\n7. have appropriate organ function during the screening period:\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study drug administration and be willing to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration; for male subjects whose partner is a female of childbearing potential, he\u002Fshe should be surgically sterilized or agree to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration. 3 months after the final study dose.\n9. Participation in other clinical trials during the study period is not permitted.\n\nExclusion Criteria:\n\n1. previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).\n2. Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.\n3. Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.\n4. Myocardial infarction, severe\u002Funstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.\n5. systemic antibiotic use for ≥ 7 days within 4 weeks prior to study entry or unexplained fever \\> 38.5°C during screening\u002Fprior to first dose (fever due to oncologic causes is eligible for enrollment at the discretion of the investigator).\n6. Presence of hydrothorax, ascites, or pericardial effusion uncontrolled with effective therapy within 14 days prior to study entry.\n7. Presence of any prior treatment-induced, unabated adverse event Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 2 or greater toxicity (excluding anemia, alopecia, and skin hyperpigmentation).\n8. Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia).\n9. Human Immunodeficiency Virus (HIV) infection or known Acquired Immune Deficiency Syndrome (AIDS), untreated active hepatitis (Hepatitis B, defined as HBV-DNA ≥ 500 IU\u002Fml; and Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with Hepatitis B and Hepatitis C.\n10. Known or suspected history of allergy to any of the drugs of interest used in the study.\n11. Pregnant or lactating women.\n12. Women of childbearing potential (\\\u003C 2 years after last menstrual period) or men of childbearing potential who are not using or refuse to use an effective non-hormonal contraceptive.\n13. Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":165,"type":21},42,[24],"A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer",[169],"Advanced Colorectal Cancer","2025-05-29",{"date":172,"type":32},"2025-06-02",{"date":174,"type":21},"2025-05-20",{"date":176,"type":21},"2028-05-20",{"name":38,"class":39},""]