[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-colorectal-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,57,82,111,134,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100637706","phase-1-dual-targeting-car-nk-cells-in-biomarker-selected-advanced-colorectal-cancer-100637706",false,"NCT07589517","Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer","A Phase 1\u002F2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and\u002For GUCY2C (GCC) With an Exploratory HER2\u002FERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","DUO-CRC-NK-111","Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.\n* Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).\n* Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.\n* Recovered to Grade ≤1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).\n* Life expectancy ≥ 12 weeks.\n* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled HBV\u002FHCV) or known uncontrolled HIV infection.\n* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)\n* Prior gene-modified cellular therapy (CAR-T\u002FCAR-NK\u002FTCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.\n* Pregnant or breastfeeding.\n* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.\n* Known hypersensitivity to study chemotherapy components (fludarabine\u002Fcyclophosphamide) or required supportive medications.\n* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.","ALL","18 Years","75 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy\u002Fbiomarker signals) will be selected for dose expansion.",[29,30,31],"Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","Unresectable Colorectal Cancer",[33,34,35,36,37,38,39,40,41,42,43],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","HER2","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","RECRUITING","2026-05-10",{"date":47,"type":48},"2026-05-15","ACTUAL",{"date":50,"type":48},"2026-02-02",{"date":52,"type":22},"2028-03-17",{"name":54,"class":55},"Beijing Biotech","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100632108","phase-2-fmt-combined-with-standard-first-line-therapy-in-initially-unresectable-colorectal-cancer-100632108","NCT07509398","FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer","Efficacy and Safety of Fecal Microbiota Transplantation Combined With First-Line Standard Therapy in Patients With Initially Unresectable Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* (1) Subjects must volunteer to participate in this study, sign the informed consent form (ICF), and demonstrate good compliance.\n\n  (2) Patients aged 18 to 75 years (inclusive). (3) Meet the defined criteria for initially unresectable advanced metastatic colorectal cancer (mCRC) for this project.\n\n  (4) Have not received first-line standard therapy. (5) Prior radiotherapy is permitted, provided it was completed more than 4 weeks prior to enrollment.\n\n  (6) ECOG performance status of 0 to 1. (7) Life expectancy of ≥ 24 weeks. (8) Adequate major organ function meeting the following criteria (without the use of any blood components or cell growth factors within 2 weeks prior to enrollment): (9) Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, white blood cell (WBC) count ≥ 4.0 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL.\n\n  (10) Hepatic function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); if total bilirubin \\> 1.5 × ULN, direct bilirubin must be ≤ ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (allowed up to 5 × ULN for patients with liver metastases).\n\n  (11) Renal function: Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL\u002Fmin).\n\n  (12) Cardiac function: Normal cardiac function with a left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  (13) Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n  (14) Male or female patients of childbearing potential must volunteer to use effective contraceptive methods (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices) during the study and for 6 months after the last dose of study medication. All female patients are considered to be of childbearing potential unless they are naturally postmenopausal, artificially postmenopausal, or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or pelvic irradiation). Otherwise, female patients must have a negative serum pregnancy test (within 7 days prior to study enrollment) and must not be lactating.\n\nExclusion Criteria:\n\n* (1) Presence of symptoms such as bleeding, perforation, or obstruction at the primary tumor site.\n\n  (2) Presence of secondary intracranial tumors (brain metastases). (3) History of severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n\n  (4) Symptomatic interstitial lung disease, or active infectious\u002Fnon-infectious pneumonitis.\n\n  (5) Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or other known risk factors for intestinal perforation.\n\n  (6) Patients who have undergone other surgeries must wait for complete wound healing before being considered for enrollment.\n\n  (7) History of other malignancies; except for cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and carcinoma in situ of the prostate, cervix, or breast, which are permitted for enrollment.\n\n  (8) Patients planning to undergo or who have previously undergone organ transplantation or allogeneic bone marrow transplantation.\n\n  (9) Moderate to severe ascites with clinical symptoms requiring therapeutic paracentesis or drainage, or a Child-Pugh score \\> 2 (excluding cases with only a small amount of ascites shown on imaging without clinical symptoms); uncontrolled or moderate to large pleural or pericardial effusions.\n\n  (10) History of gastrointestinal bleeding within 6 months prior to the start of study treatment or a clear tendency for gastrointestinal bleeding, such as esophageal\u002Fgastric varices with bleeding risk or severe varices, localized active gastrointestinal ulcer lesions, or persistently positive fecal occult blood (if fecal occult blood is positive at baseline, it can be retested; if still positive, an esophagogastroduodenoscopy (EGD) is required. If EGD indicates esophageal\u002Fgastric varices with a risk of bleeding, the patient cannot be enrolled).\n\n  (11) Occurrence of an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment.\n\n  (12) Patients who presented with signs\u002Fsymptoms of incomplete obstruction\u002Fobstructive syndrome\u002Fileus at initial diagnosis may be enrolled if the symptoms have completely resolved following definitive (surgical) treatment.\n\n  (13) Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; current or recent (within 10 days prior to study treatment) use of full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed).\n\n  (14) Current or recent (within 10 days prior to study treatment) use of aspirin (\\> 325 mg\u002Fday, maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel (≥ 75 mg), or cilostazol.\n\n  (15) Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n\n  (16) Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmias.\n\n  (17) Lactating or pregnant women. (18) History of hepatic encephalopathy. (19) Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose \\> 10 mg\u002Fday of prednisone or equivalent) within 14 days prior to the start of study treatment.\n\n  (20) Known severe allergic reaction to any monoclonal antibodies or anti-angiogenic targeted drugs.\n\n  (21) Any other factors that, in the judgment of the investigator, may affect the study results or lead to premature termination of the study, such as alcohol abuse, drug abuse, other severe diseases (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.",{"count":65,"type":22},220,[26,67],"PHASE3","This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC).\n\nFMT is an established procedure designed to restore intestinal microbiome homeostasis by transferring processed fecal microbiota from a rigorously screened healthy donor into the patient's gastrointestinal tract. The standard first-line treatment regimen typically consists of chemotherapy, with or without targeted therapy.\n\nApproximately 220 patients across 13 participating centers will be randomly assigned to receive either standard therapy alone or standard therapy combined with FMT. The primary endpoint is the objective response rate (ORR). Secondary endpoints include the conversion to resectability rate, progression-free survival (PFS), safety and adverse events, quality of life (QoL), anxiety and depression scales, as well as dynamic changes in the gut microbiome and circulating biomarkers.\n\nThe ultimate goal of this trial is to determine whether microbiome modulation via FMT can synergistically enhance the antitumor efficacy of standard first-line therapies and mitigate treatment-related toxicities in this patient population.",[31,70],"Colorectal Cancer (Locally Advanced or Metastatic)","NOT_YET_RECRUITING","2026-03-29",{"date":74,"type":48},"2026-04-03",{"date":76,"type":22},"2026-04",{"date":78,"type":22},"2031-12",{"name":80,"class":81},"Shanghai 10th People's Hospital","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":56},"100618548","clinical-efficacy-of-transarterial-infusion-chemotherapy-for-unresectable-colorectal-cancer-100618548","NCT07333053","Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer","FOLFOX-Based Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer: An Open-Label, Multicenter, Randomized, Controlled, Phase Ⅱ Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Colorectal cancer confirmed by CT\u002FMRI and colonoscopic biopsy；\n3. Patients unfit for surgery due to poor general condition or tumor extent and location;\n4. Patients who have not received prior chemotherapy or those who have undergone prior chemotherapy but remain chemosensitive.\n5. Adequate haematological, heart, liver and renal functions are required, with the following specific criteria: white blood cell count≥4000\u002FmL, neutrophils≥1500\u002Fmm³, platelets≥100×10⁹\u002FL, haemoglobin≥10.0 g\u002FL, total bilirubin 2.0 mg\u002FdL, aspartate aminotransferase 100 IU\u002FL, alanine aminotransferase 100 IU\u002FL, serum creatinine 1.5 mg\u002FdL or creatinine clearance rate≥60 mL\u002Fmin\u002Fbody, and urine protein\u002Fcreatinine\\\u003C1.\n6. Patients have to have an expected life expectancy of ≥3months.\n7. All the subjects in this study are required to sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with other primary malignant tumors;\n2. Patients with gastrointestinal perforation;\n3. Patients are allergic to the antitumor agents;\n4. Women who are pregnant, breastfeeding, or planning to become pregnant;\n5. Patients who receive other antitumor therapies concurrently, such as chemotherapy, targeted therapy, or radiotherapy;\n6. Patients with MSI-H\u002FdMMR CRC；\n7. Patients for whom participation in the study is deemed to be inappropriate by the doctor in charge and\u002For the investigator for any other reasons.",{"count":90,"type":22},30,[92],"NA","This is a prospective, multicenter, randomized, and open-label clinical trial. It is initiated to determine the efficacy of FOLFOX-based, transarterial infusion chemotherapy (TAIC) combined with either cetuximab or bevacizumab for patients with unresectable colorectal cancer (CRC).",[31],[96,97,98,29,99,100,101],"Transarterial Infusion Chemotherapy","Bevacizumab","Cetuximab","FOLFOX Protocol","Unresectable","Clinical Trial","2026-03-05",{"date":104,"type":48},"2026-03-06",{"date":106,"type":22},"2026-03-31",{"date":108,"type":22},"2027-12-31",{"name":110,"class":81},"Quanda Liu",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100609040","phase-2-clinical-efficacy-of-transarterial-chemoembolization-in-elderly-patients-with-advanced-unresectable-colorectal-cancer-100609040","NCT07209384","Clinical Efficacy of Transarterial Chemoembolization in Elderly Patients With Advanced Unresectable Colorectal Cancer","CLINICAL EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION IN ELDERLY PATIENTS WITH ADVANCED UNRESECTABLE COLORECTAL CANCER","Inclusion Criteria:\n\n* Age ≥ 65 years, gender not restricted Pathologically confirmed advanced colorectal cancer without the opportunity for curative surgery Karnofsky Performance Status (KPS) score ≥ 60, with an estimated survival time ≥ 3 months At least 1 measurable colorectal lesion No prior systemic chemotherapy, or a minimum interval of 6 months between the last chemotherapy and study enrollment Voluntary signing of the informed consent form\n\nExclusion Criteria:\n\n* Concomitant other malignant tumors Presence of gastrointestinal perforation Severe cardiovascular and cerebrovascular diseases Patients with hypersensitivity to study drugs or psychiatric disorders","65 Years",{"count":120,"type":22},50,[26],"We plan to conduct a prospective, two-arm, open-label phase Ⅱ study to evaluate whether transarterial chemoembolization with FOLFOX plus\u002Fminus intravenous cetuximab\u002Fbevacizumab significantly improves the efficacy and safety compared with systemic FOLFOX therapy plus\u002Fminus cetuximab\u002Fbevacizumab in elderly patients with advanced unresectable colorectal cancer.",[31,124,125],"Advanced Malignancy","Elderly (People Aged 65 or More)","2025-10-01",{"date":128,"type":48},"2025-10-07",{"date":126,"type":22},{"date":131,"type":22},"2026-10-01",{"name":133,"class":81},"Junpeng Wang",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100602543","phase-2-5-fluorouracil-plus-panitumumab-anti-egfr-and-sotorasib-kras-g12c-inhibitor-in-first-line-treatment-of-patients-non-eligible-for-a-doublettriplet-chemotherapy-with-advanced-unresectab-100602543","NCT07124884","5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO: Single-arm Phase II Study Evaluating 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.\n* Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test\n* Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).\n* Patient with one these criteria:\n\nPatient with WHO PS=2 Patient between 70 and 75 years old with WHO PS 1 Patient ≥ 75 years old\n\n* Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).\n* No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed if there is more than 6 months between the end of adjuvant treatment and relapse.\n* Adequate organ function: Hemoglobin \\> 9 g\u002Fdl, Absolute neutrophil count \\> 1500 \u002Fmm3, Platelets \\> 80 000\u002Fmm3, Creatinine clearance rate ≥50 mL\u002Fmin as calculated using MDRD formula, ALT\u002FAST ≤5×ULN and total bilirubin ≤1.5×ULN.\n* Ability to understand and sign written informed consent to participate in the study.\n* Provides written informed consent for the study.\n* Life expectancy \\>6 months.\n* Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments.\n* Patient affiliated to a social security scheme for France, or equivalent for other countries.\n\nExclusion Criteria:\n\n\\- Patient with one of these criteria: Patient fit for doublet\u002Ftriplet regimen Patient with WHO PS 3 or 4 Patient \\\u003C 75 years old with WHO PS 0 Patient \\\u003C 70 years old with WHO PS 0 or 1\n\n* Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume \\\u003C50%) severe insufficiency.\n* Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).\n* Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).\n* Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng\u002FmL).\n* Immunotherapy within 3 months before the beginning of the treatment study.\n* Patient under treatment by strong CYP3A4 inducers.\n* Patients treated by brivudine within 4 weeks before the first dose of study treatment, or concomitant treatment with brivudine.\n* Patient with potentially serious infection.\n* Administration of live or live attenuated vaccine within 30 days prior to the first dose of study treatment start.\n* Poor nutritional state (albuminemia \\\u003C 25 g\u002FL or weight loss \\> 10% during the last month).\n* Hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption.\n* Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated.\n* Less than 4 weeks from major surgeries and not recovered adequately from the procedure and\u002For any complications from the surgery.\n* Patients with persistent toxicities related to prior treatment of grade greater than 1.Is c urrently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry.\n* Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments.\n* Patient with interstitial lung disease or pulmonary fibrosis.\n* Patients with history of interstitial pneumonitis or pulmonary fibrosis.\n* Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.\n* Pregnant or breastfeeding woman.\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.",{"count":143,"type":22},300,[26],"5-fluorouracil (5-FU) is a standard of care in frail\u002Felderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail\u002Felderly patients with unresectable KRAS G12C mutated CRC",[147,148,31],"Colorectal Carcinoma","KRAS G12C Mutation",[150,151,152],"sotorasib","colorectal cancer","KRAS G12C","2025-08-14",{"date":155,"type":48},"2025-08-15",{"date":157,"type":22},"2025-08-31",{"date":159,"type":22},"2030-12-30",{"name":161,"class":81},"Federation Francophone de Cancerologie Digestive",80,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":188,"locationsCount":56},"100593646","phase-2-ql1706-plus-bevacizumab-for-unresectable-or-metastatic-msi-hdmmr-crc-100593646","NCT07009145","QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H\u002FdMMR CRC","An Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Bevacizumab for the Treatment of Unresectable or Metastatic MSI-H\u002FdMMR Colorectal Cancer","Inclusion Criteria:\n\n* Voluntarily signs the informed consent form.\n* Aged between 18 and 80 years (inclusive) at the time of consent; no gender restriction.\n* Histologically confirmed unresectable locally advanced or metastatic colorectal cancer.\n* At least one measurable target lesion according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No prior immunotherapy for unresectable locally advanced or metastatic colorectal cancer.\n* If previously treated with standard neoadjuvant or adjuvant therapy, the interval from the last dose to the first study treatment must be ≥ 6 months.\n* Willing and able to provide tumor tissue and blood samples for MSI, RAS, BRAF, and PD-L1 testing.\n* Estimated life expectancy of ≥ 12 months.\n* Appropriate laboratory values must be met at screening.\n* Female participants must be non-lactating, and have a negative pregnancy test result prior to enrollment.\n* Participants of childbearing potential must agree to use effective contraception from the time of informed consent until at least 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Known history of severe allergic reactions to iparomlimab and tuvonralimab or bevacizumab.\n* Active malignancy other than colorectal cancer within 5 years prior to first treatment.\n* Large tumor lesions, especially those previously irradiated, with signs of bleeding.\n* Imaging showing tumor invasion of major blood vessels (e.g., pulmonary artery or superior vena cava), including encasement or invasion of the vessel lumen.\n* Brain metastases (asymptomatic or treated symptomatic brain metastases stable for \\>4 weeks allowed).\n* Active autoimmune disease requiring systemic treatment.\n* Active pulmonary diseases such as tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction during screening.\n* Requirement for long-term or high-dose NSAIDs (aspirin \\>325 mg) or anticoagulant therapy.\n* History of severe gastrointestinal events within 6 months prior to first treatment.\n* Severe intestinal obstruction symptoms or signs and unretrieved intestinal stents at screening.\n* Cardiovascular or cerebrovascular diseases including but not limited to: NYHA class \\> II heart failure; unstable or severe angina; myocardial infarction or stroke within 6 months; atrial fibrillation or other arrhythmias requiring treatment; symptomatic superior vena cava syndrome; prolonged QT interval (male QT \\> 450 ms; female QTc \\> 470 ms); uncontrolled hypertension despite medication (SBP \\>140 mmHg and\u002For DBP \\>90 mmHg) or history of hypertensive crisis or encephalopathy.\n* Known bleeding disorders or coagulopathies.\n* Uncontrolled pleural, pericardial, or ascitic effusions requiring drainage.\n* Active infection or unexplained fever \\>38.5°C at screening (cancer-related fever allowed).\n* Use of systemic broad-spectrum antibiotics within 30 days prior to first treatment.\n* Systemic corticosteroids (\\>10 mg prednisone equivalent daily) or immunosuppressants within 14 days prior to first treatment, or immunostimulants within 4 weeks.\n* Major surgery, severe fractures, or therapeutic clinical trials within 4 weeks prior to first treatment; herbal treatment within 2 weeks.\n* Ongoing adverse events from prior antitumor therapy greater than grade 1.\n* HIV infection, other congenital or acquired immunodeficiencies, or history of organ or allogeneic bone marrow transplantation (except corneal transplantation).\n* Positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV DNA \\>10⁴ copies\u002FmL (\\~2000 IU\u002FmL); or positive hepatitis C antibody with HCV RNA \\>10³ copies\u002FmL; co-infection with HBV and HCV excluded.\n* Vaccination with live or attenuated vaccines within 30 days prior to first treatment.\n* Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137).\n* Prior adjuvant targeted therapy against EGFR, VEGF, or VEGFR (e.g., bevacizumab, cetuximab, panitumumab, apatinib, regorafenib, anlotinib).\n* Psychiatric disorders, epilepsy, dementia, or substance abuse that may affect compliance.\n* Other conditions or lab abnormalities that may interfere with study participation or confound results as judged by investigators or sponsors.","80 Years",{"count":172,"type":22},22,[26],"This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg\u002Fkg and bevacizumab at 7.5 mg\u002Fkg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.",[31,176,177],"Metastatic Colorectal Cancer (CRC)","MSI-H\u002FdMMR Colorectal Cancer",[179,180,181],"QL1706","CRC","MSI-H\u002FdMMR","2025-05-28",{"date":184,"type":48},"2025-06-06",{"date":186,"type":22},"2025-06-27",{"date":108,"type":22},{"name":189,"class":81},"Qianfoshan Hospital"]