[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colorectal-cancer-crc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colorectal-cancer-crc":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,45,74,100,152,176,206,237,259,283,309,333,355,375,399,421,442,463,484,513,532,559,581,605,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100610534","phase-3-phase-iii-study-of-ivonescimab-or-bevacizumab-combined-with-folfox-in-patients-with-metastatic-colorectal-cancer-100610534",false,"NCT07228832","Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer","A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer","HARMONi-GI3","Inclusion Criteria:\n\n1. ECOG performance status score of 0 or 1\n2. Expected life expectancy ≥ 6 months\n3. Patients with histologically or cytologically confirmed metastatic CRC\n4. No prior systemic therapy for metastatic CRC\n5. At least 1 measurable noncerebral lesion\n\nExclusion Criteria:\n\n1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease\n2. Known BRAF V600E mutant status\n3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction\n4. Ascites requiring paracentesis within last 30 days\n5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer\n6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n7. Resectable disease","ALL","18 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)",[28],"Metastatic Colorectal Cancer (CRC)",[30,31],"mCRC","Ivonescimab","RECRUITING","2026-06-18",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2025-11-18",{"date":40,"type":22},"2029-11-30",{"name":42,"class":43},"Summit Therapeutics","INDUSTRY",130,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100640989","phase-2-folfox8-versus-mfolfox6-with-bevacizumab-or-cetuximab-for-first-line-unresectable-metastatic-colorectal-cancer-phase-ii-100640989","NCT07621497","FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)","A Prospective, Multicenter, Randomized Controlled, Phase II Study to Evaluate the Efficacy and Safety of FOLFOX8 Versus mFOLFOX6 Combined With Bevacizumab or Cetuximab as First-Line Treatment for Unresectable Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. ECOG performance status 0-2.\n3. Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease.\n4. Adequate organ function: Hb ≥ 70 g\u002FL; WBC ≥ 3.0×10⁹\u002FL; NEUT ≥ 1.5×10⁹\u002FL; PLT ≥ 75×10⁹\u002FL; AST and ALT ≤ 3× ULN; sCr ≤ 2× ULN; TBIL ≤ 2× ULN.\n5. Expected survival \\> 3 months.\n\nExclusion Criteria:\n\n1. Known allergy to the study drug(s) and\u002For their excipients.\n2. Contraindications to chemotherapy.\n3. Patients with MSI-H or dMMR colorectal cancer.\n4. Patients with BRAF mutation.\n5. Pregnant or breastfeeding women.\n6. History of any second malignancy within 2 years prior to randomization, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ, which are allowed for enrollment.\n7. Patients with systemic medical or psychiatric disorders that make them unsuitable for chemotherapy.\n8. Patients deemed unsuitable for enrollment in this study by the investigator's judgment.\n9. Participation in another clinical trial of an investigational drug within 4 weeks prior to randomization.",{"count":53,"type":22},229,[55],"PHASE2","This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.",[28],[59,60,61],"FOLFOX8","Levofolinic Acid For Injection","First-line treatment","NOT_YET_RECRUITING","2026-05-31",{"date":65,"type":36},"2026-06-02",{"date":67,"type":22},"2026-06-01",{"date":69,"type":22},"2030-06-01",{"name":71,"class":72},"Sun Yat-sen University","OTHER",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":73},"100631409","phase-1-phase-1-study-of-sar445877-in-combination-with-folfox6-and-bevacizumab-as-first-line-treatment-for-microsatellite-stable-metastatic-colorectal-cancer-100631409","NCT07500298","Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer","Eligibility Criteria\n\n1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.\n2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.\n3. Age ≥18 years.\n4. Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at the time of enrollment.\n5. CRC documented as MSS by immunohistochemistry, next-generation sequencing, or polymerase chain reaction assay at any time prior to screening.\n6. Measurable disease per the RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ and marrow function as defined below within 28 days of study treatment initiation:\n\n   * Hemoglobin \\>9.0 g\u002FdL\n   * Absolute neutrophil count ≥1500\u002FmL\n   * Platelets ≥100,000\u002FmL\n   * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.\n   * Estimated glomerular filtration rate ≥50 mL\u002Fmin\u002F1.73 m² (Modification of Diet in Renal Disease Formula)\n   * For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.\n9. Life expectancy ≥ 3 months.\n10. The effects of SAR445877 and FOLFOX\u002Fbevacizumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of the study treatment period, and for 9 months after completion of study treatment.\n\n    (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \\[MDACC\\] Institutional Policy # CLN1114). WOCBP includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in ≥12 consecutive months)\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)\n    * History of bilateral tubal ligation or another surgical sterilization procedure\n    * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, patient\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the duration of the study treatment period and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Male participants must agree to use adequate contraception throughout the duration of the study treatment period and for 6 months after the last dose of study treatment\n12. WOCBP must have a negative serum pregnancy test within 3 days prior to first administration of study treatment.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding.\n2. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires\u002Frequired treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. Participants with the following conditions are eligible: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.\n3. Participants who are receiving any other investigational agents.\n4. Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n5. Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 1 week prior to the first administration of study treatment. Physiologic replacement doses are allowed even if they are \\>10 mg of prednisone\u002Fday or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided they are not for the treatment of an autoimmune disorder. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are eligible to be enrolled in the study.\n6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells\u002Fmm3.\n7. Acute or chronic hepatitis B virus or hepatitis C virus infection.\n8. Previous solid organ or allogeneic hematopoietic stem cell transplant.\n9. Active brain or leptomeningeal metastases.\n10. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n11. History of interstitial lung disease or severe obstructive pulmonary disease.\n12. Clinically significant cardiovascular\u002Fcerebrovascular disease.\n13. Left ventricular ejection fraction \\\u003C50% as measured by echocardiogram or multigated acquisition scan.\n14. Serious, non-healing wound, ulcer, or bone fracture.\n15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first administration of study treatment.\n16. Evidence of bleeding or coagulopathy.\n17. Uncontrolled hypertension (\\>150\u002F100 mmHg).\n18. Urine dipstick of proteinuria \\>2+. Participants with \\>2+ proteinuria on dipstick analysis will undergo a 24-hour urine collection and must demonstrate \\\u003C1.0 g protein\u002F24 hours to be eligible.\n19. Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) anaphylaxis.\n20. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n21. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n\n    \\-",{"count":81,"type":22},41,[83],"PHASE1","To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.",[86,87,88,89,90,28,91],"Phase 1","SAR445877","FOlfox6","Bevacizimab","First Line Treatment","Microsatellite Stable","2026-05-29",{"date":67,"type":36},{"date":95,"type":36},"2026-05-20",{"date":97,"type":22},"2032-12-27",{"name":99,"class":72},"M.D. Anderson Cancer Center",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":125,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":108,"type":22},665,[83],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[112,113,114,115,116,28,117,118,119,120,121,122,123,124],"Non-Small Cell Lung Cancer","NSCLC","PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma","Solid Tumor, Adult",[126,127,128,129,113,130,131,132,133,134,135,136,137,138,139,140,141,142,143],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","CRC","PDAC","Metastatic Cancer","Advanced Cancer","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel",{"date":65,"type":36},{"date":146,"type":36},"2025-03-31",{"date":148,"type":22},"2029-09",{"name":150,"class":43},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",17,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100639050","phase-2-a-single-arm-multicenter-clinical-study-of-fruquintinib-combined-with-serplulimab-and-chemotherapy-as-first-line-treatment-for-patients-with-rasbraf-mutated-advanced-colorectal-cance-100639050","NCT07622550","A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS\u002FBRAF-mutated Advanced Colorectal Cance","Inclusion Criteria:\n\n* 18 to 75 years (inclusive), male or female.\n* Diagnosis of advanced unresectable or metastatic colorectal cancer.\n* Confirmed RAS\u002FBRAF mutation by testing.\n* No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)\n* ECOG 0 - 1.\n* Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):\n\n  1. Hematology: absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  2. International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n  3. Liver function: total bilirubin ≤1.5 × ULN; ALT\u002FAST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).\n  4. Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL\u002Fmin.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose\n\nExclusion Criteria:\n\n* \\- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.\n* Untreated central nervous system (CNS) metastases.\n* Major surgery or severe trauma within 4 weeks prior to first study drug administration.\n* Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), and continued use within 2 weeks before enrollment.\n* Presence of any active autoimmune disease or history of autoimmune disease.\n* History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Known inherited or acquired bleeding\u002Fthrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.\n* Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).","75 Years",{"count":160,"type":22},80,[55],"This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS\u002FBRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS\u002FBRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.",[28],[165],"RAS\u002FBRAF-mutated","2026-05-28",{"date":168,"type":36},"2026-06-03",{"date":170,"type":22},"2026-06-15",{"date":172,"type":22},"2028-08-15",{"name":174,"class":72},"Jiangsu Cancer Institute & Hospital",16,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100602541","prospective-national-cohort-evaluating-prognostic-factors-for-efficacy-of-fruquintinib-treatment-in-patients-with-metastatic-colorectal-cancer-100602541","NCT07124858","Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer","PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer","COFRUQ","Inclusion Criteria:\n\n* Patients aged 18 and over.\n* Histologically confirmed colorectal adenocarcinoma with locally advanced disease and\u002For unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate\u002Fearly access and ii) marketing authorisation and reimbursement in France.\n* Obtain informed consent from the patient for the clinical-biological cohort.\n* Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).\n\nExclusion Criteria:\n\n* Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).\n* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).\n* Pregnant or breast-feeding women.\n* Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).",{"count":185,"type":22},300,[187],"NA","The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.",[28,190,191],"Antineoplastic Agents, Immunological","VEGFR-TKI",[193,194,195],"Metastatic colorectal cancer","Fruquintinib","cohort","2026-05-22",{"date":198,"type":36},"2026-05-26",{"date":200,"type":36},"2026-03-10",{"date":202,"type":22},"2031-12-31",{"name":204,"class":72},"Federation Francophone de Cancerologie Digestive",83,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100638163","phase-1-study-evaluating-the-safety-feasibility-and-efficacy-of-odi-2001-vaccine-a-personnalized-immunotherapy-in-patients-with-metastatic-or-locally-advanced-colon-cancer-or-pancreatic-cancer-100638163","NCT07587827","Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","ODI-2001-01","Inclusion Criteria:\n\n* Patient capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Male or female of \\> 18 years of age\n* Histologically confirmed diagnosis of metastatic or locally advanced solid tumour: • Colorectal carcinoma with MicroSatellite Stable colorectal carcinoma (MSS) not eligible for surgery or other ablative therapies. • Pancreatic adenocarcinoma not eligible for surgery or other ablative therapies.\n* ECOG performance status 0 or 1\n* Baseline Tumoral evaluation (thoraco-abdomino-pelvic computed tomography) performed before the initiation of the standard first line-chemotherapy with at least one measurable lesion according to RECIST 1.1 criteria that can be accurately assessed at baseline and is suitable for repeated assessment.\n* Eligible to start a standard first line chemotherapy indicated in colorectal cancer (FOLFOX\u002FFOLFIRI\u002FFOLFIRINOX or FOLFOXIRI +\u002F- anti-VEGF\u002FEGF) pancreatic cancer (FOLFIRINOX\u002FNabPaclitaxel-Gemcitabine).\n* Adequate haematological, renal and hepatic laboratory requirements : • Haemoglobin \\> 9.0 g\u002FdL • White Blood Cells (WBC) \\> 2.5x109\u002FL including, absolute neutrophils count (ANC) \\> 1.5x109\u002FL, total lymphocytes count \\> 0.5x109\u002FL • Platelet's count \\> 100x109\u002FL• Serum alkaline phosphatase (PAL) ≤ 3 x ULN in the absence of liver or bone metastases and ≤ 5 x ULN in patients with documented bone or liver metastases• Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN in the absence of liver metastases and ≤ 5 x ULN in case of liver metastases\n\n  • Total bilirubin ≤ 1.5 x ULN• Albumin ≥ 30 g\u002FL • Glomerular Filtration Rate ≥ 50 mL\u002Fmin (according to Modification of the Diet in Renal Disease \\[MDRD\\] formula or Cockroft \\& Gault formula)\n* Adequate cardiac function with QTc \\\u003C 450 msec on baseline ECG, using the Fridericia correction cQTcF formula\n* Life expectancy of at least 6 months\n* Patient willing and able to comply with scheduled visits and exams during the follow-up and treatment compliance of the protocol, for the duration of the study including : • mandatory blood sampling (3 blood sampling) • mandatory biopsy of the tumor following enrolment in STEP 1 if no archived material dated less than 2 years is available in sufficient quality or quantity and a mandatory biopsy at 2 months after the initiation of ODI-2001 vaccine administration.\n* Men who are sexually active with women of childbearing potential must agree to use contraceptive method during the ODI-2001 treatment period and for at least 4 months after the last ODI-2001 administration. The individual methods of contraception may be determined in consultation with the investigator and it must have a failure rate of less than 1% per year.\n* A female participant is eligible to participate if she is not pregnant (negative urinary or serum pregnancy test), not breastfeeding, and at least one of the following conditions applies: • Not a woman of childbearing potential OR • Women of childbearing potential who agrees to apply effective contraception method during the treatment period and for at least 4 months after the last dose of study treatment. Effective contraception methods include a combination of any of the following (unless method is abstinence or sterilization, in which only one method is required): - Use of oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 6 months before taking study treatment. - Placement of an intrauterine device or intrauterine system. - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository. - Total abstinence - Female sterilization at least eight weeks before taking study treatment. - Male sterilization (at least six months prior to screening)\n* Patient must be affiliated to a social health insurance regimen\n\nInclusion criteria for ENROLMENT STEP 1 :\n\nFirst tumoral evaluation shows disease response with the following definition:\n\n* Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n* Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n\n  * Availability of tumoral material in sufficient quality and quantity in FFPE to performed dB209 manufacturing (5-10 slides according to tissue surface area) + tumoral microenvironment assessment (10 slides). In case of lack of tumoral material to performed the mandatory 2 analysis, a new biopsy should be organized.\n\nInclusion criteria for ENROLMENT STEP 2\n\n* Second tumoral evaluation shows disease response with the following definition:\n\n  * Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n  * Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n* Patient eligible for a 6-week chemotherapy break, with the start of maintenance treatment beginning in week 7.\n\nExclusion Criteria:\n\n* Patients with \\>10% hepatic involvement as per investigator\n* Exposure to any investigational agent within 30 days of enrolment.\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* History of any second malignancy within 2 years with the exception of malignancies with a negligible risk of metastasis or death (e.g. adequately treated carcinoma-in situ of the breast or the cervix, melanoma-in-situ, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range).\n* Known or suspected history of immunosuppression (severe auto-immune or immunodeficiency disease) including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever\n* Patients with major surgery within 4 weeks from enrolment\n* Previous vaccination (either therapeutic and\u002For prophylactic) against cancer\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) unless used at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg\u002Fday or less or as inhaled steroid at doses used for the treatment of asthma) up to 14 days before pre-enrolment.\n* Is receiving growth factors including, but not limited to, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 4 weeks from enrolment\n* Known history of Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence of HBs antigen in the serum\n* History of severe auto-immune or immunodeficiency disease\n* Known allergy to any of the components of ODI-2001 (e.g. egg or gentamycin)\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty\n* Planned to receive yellow fever or other live (attenuated) vaccines during the course of the study\n* Recent or active clinically significant infection requiring therapy at the time of first dose\n* Any persistent or unresolved drug-related toxicity following previous treatment\n* Myocardial infarction or stroke within previous 6 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure\n* Known symptomatic malignant brain lesion\n* Patients with any serious uncontrolled disease or psychiatric condition that, in the opinion of the Investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results",{"count":215,"type":22},77,[83],"This is a phase 1, open-label, multicentric study evaluating the safety, feasibility and efficacy of ODI-2001, a personnalized therapeutic cancer vaccine composed of DNA neoantigen vaccine, Modified Vaccinia virus Ankara (MVA) viral adjuvant and anti-CTLA4 (ipilimumab), in patients with metastatic or locally advanced colorectal or pancreatic cancer. The study includes a dose-escalation phase to determine the maximum tolerated dose (MTD) followed by an expansion phase to evaluate efficacy in terms of progression-free survival",[28,219,220,221],"Locally Advanced Colorectal Cancer","Metastatic Pancreatic Cancer","Locally Advanced Pancreatic Cancer",[223,224,225,226],"vaccine","pancreas","colorectal","phase 1","2026-05-11",{"date":229,"type":36},"2026-05-14",{"date":231,"type":22},"2026-11-01",{"date":233,"type":22},"2031-05-01",{"name":235,"class":72},"Centre Georges Francois Leclerc",2,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":257,"locationsCount":73},"100640153","phase-2-a-clinical-study-of-liposomal-irinotecan-for-second-line-therapy-in-metastatic-colorectal-cancer-100640153","NCT07585279","A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer","Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II\u002FⅢ Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years old and ≤ 75 years old.\n2. Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;\n3. Patients must have at least one measurable lesion according to RECIST 1.1 criteria.\n4. Had received first-line treatment based on oxaliplatin.\n5. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;\n6. Expected survival time ≥3 months.\n7. Adequate organ function, meeting the following laboratory test standards:\n\n1\\) Bone marrow function: Neutrophils≥1.5×109\u002FL, Platelets≥100×109\u002FL, Hemoglobin≥90 g\u002FL, White blood cells ≥3.0×109\u002FL; 2) Liver function:Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase≤2.5×upper limit of normal (ULN), when there is liver metastasis, ≤ 5×ULN; Total bilirubin≤1.5×ULN; 3) Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 60 ml\u002Fmin, Urine protein≤2+; 4) Coagulation function: Activated partial thromboplastin time and International Normalized Ratio ≤1.5 × ULN; 5) Thyroid function: Thyroid stimulating hormone≤ULN; If abnormal, additional tests for FT3 and FT4 should be conducted and their levels should be normal; 6) Albumin≥3 g\u002FdL; 8. Pregnant women of childbearing age with negative pregnancy test and non-lactating, participants with reproductive capacity must receive effective contraceptive measures; 9. Patients and\u002For legal representative must have the ability to understand and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell carcinoma of the skin.\n2. Prior treatment with irinotecan or liposomal irinotecan-based chemotherapy, or prior treatment with immune checkpoint inhibitors (including but not limited to PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors).\n3. Patients with left-sided colorectal cancer, RAS\u002FBRAF wild-type, who did not receive cetuximab in first-line therapy.\n4. Patients with known mismatch repair dysfunction or microsatellite instability ;\n5. Patients with a large amount of pleural effusion or ascites that require drug intervention treatment;\n6. Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, who show persistent signs\u002Fsymptoms without improvement despite appropriate antimicrobial therapy.\n7. Known active HIV infection; untreated active HBV or HCV infection.\n8. Patients with uncontrolled systemic diseases, including: cardiac disease of NYHA Class II or above; uncontrolled hypertension (defined as systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg despite standard antihypertensive therapy) or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus; etc.\n9. Patients with active autoimmune diseases, or with a history of autoimmune disease within 2 years prior to enrollment that still requires systemic therapy. Exceptions include participants with well-controlled type 1 diabetes, hypothyroidism controlled with hormone replacement alone, skin disorders not requiring systemic treatment, or those in whom recurrence is not anticipated in the absence of external triggers.\n10. Patients with primary immunodeficiency diseases or with a history;\n11. Patients who have received immunosuppressant treatment within 14 days before enrollment or require daily systemic steroid treatment (such as \\> 20 mg\u002Fday prednisone or equivalent drugs), except those treated with nasal, inhalation or other routes of local glucocorticoid therapy;\n12. Patients with severe gastrointestinal diseases;\n13. History of abdominal surgery, thoracic surgery, or intestinal resection within 28 days prior to enrollment.\n14. Had interstitial lung disease or non-infectious pneumonia requiring glucocorticoid treatment;\n15. Known hypersensitivity or intolerance to the investigational drugs or their excipients.\n16. History of pulmonary hemorrhage or hemoptysis of grade 2 or higher (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment.\n17. History of arterial thromboembolism, severe bleeding (excluding surgical bleeding), or active thromboembolic or severe bleeding events within 6 months prior to enrollment.\n18. Had symptomatic central nervous system metastasis;\n19. Had strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;\n20. Receipt of intravenous antitumor therapy within 28 days, or oral antitumor medication within 14 days, prior to the first dose of study drug.\n21. Patients judged by the investigator to be unsuitable to participate in this study.",{"count":245,"type":22},408,[55,25],"Phase II - Treatment Regimen Exploration Stage:\n\n1. Evaluate the safety and efficacy of the following three treatment regimens:\n\n   Liposomal irinotecan + 5-FU\u002FLV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU\u002FLV + bevacizumab (Group B) Irinotecan + 5-FU\u002FLV + bevacizumab (Group C)\n2. Provide a basis for selecting the treatment regimen for the confirmatory phase.\n3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.\n\nPhase III - Efficacy Confirmation Stage:\n\nCompare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.",[28,249,250],"Liposomal Irinotecan","Second-Line","2026-05-07",{"date":253,"type":36},"2026-05-13",{"date":95,"type":22},{"date":256,"type":22},"2032-02-28",{"name":258,"class":72},"Hebei Medical University Fourth Hospital",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":73},"100627265","phase-2-a-clinical-study-of-iparomlimab-and-tuvonralimab-combined-with-bevacizumab-and-alternating-triweekly-capoxmcapiri-regimen-as-first-line-treatment-for-unresectable-advanced-colorectal-cancer-100627265","NCT07446387","A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX\u002FmCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX\u002FmCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age 18-75 years;\n* 2\\. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;\n* 3\\. No prior systemic treatment;\n* 4\\. ECOG PS score ≤2;\n* 5\\. Expected survival ≥3 months;\n* 6\\. MSS\u002FMSI-L status;\n* 7\\. At least one evaluable lesion based on RECIST 1.1 criteria;\n* 8\\. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment;\n* 9\\. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows:\n\n  1. White blood cell count ≥3.5×10⁹\u002FL\n  2. Absolute neutrophil count ≥1.5×10⁹\u002FL\n  3. Hemoglobin ≥100 g\u002FL\n  4. Platelets ≥80×10⁹\u002FL\n  5. Serum liver enzymes ≤2.5× upper limit of normal (ULN) in patients without liver metastases\n  6. Serum liver enzymes ≤5× ULN in patients with liver metastases\n  7. Serum bilirubin ≤1.5× ULN\n  8. Serum creatinine ≤1.5× ULN\n* 10\\. No history of other malignancies;\n* 11\\. Voluntary participation in this study with signed informed consent.\n\nExclusion Criteria:\n\n* 1\\. Prior hypersensitivity to any of the study drugs;\n* 2\\. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n* 3\\. Presence of non-measurable lesions (e.g., pleural effusion\u002Fascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);\n* 4\\. Pregnant or lactating women;\n* 5\\. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;\n* 6\\. Vital organ function failure;\n* 7\\. Conditions affecting drug absorption\u002Fdistribution\u002Fmetabolism\u002Fexcretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.);\n* 8\\. Patients with complete or incomplete intestinal obstruction;\n* 9\\. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension);\n* 10\\. Active infection requiring systemic treatment;\n* 11\\. Known history of HIV infection;\n* 12\\. Known history of hepatitis B or active hepatitis C virus infection;\n* 13\\. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":267,"type":22},70,[55],"This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX\u002FmCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX\u002FmCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.",[28],[30,272,273,274,275],"bevacizumab","QL1706","Combination therapy","Alternating chemotherapy",{"date":277,"type":36},"2026-05-12",{"date":279,"type":22},"2026-05-30",{"date":281,"type":22},"2029-12-31",{"name":174,"class":72},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":293,"phases":4,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":73},"100634163","assessing-the-efficacy-and-safety-of-ctdna-driven-selection-for-anti-egfr-retreatment-in-a-real-world-metastatic-colorectal-cancer-patients-cohort-the-realchallenge-study-100634163","NCT07536113","Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort (the REalCHALLENGE Study)","Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort","RealCHALLENGE","Inclusion criteria\n\n1. Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial;\n2. Informed consent signature from alive patient;\n3. Availability of clinical data detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial;\n4. Signed informed consent for molecular screening within the MEN1611-02 clinical trial.\n5. Age ≥ 18.\n\nExclusion criteria\n\n1. No data available detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial.\n2. Patients enrolled and treated within the MEN1611-02 clinical trial.",{"count":292,"type":22},250,"OBSERVATIONAL","This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS\u002FBRAF\u002FPIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.",[28],[297,30,298,299],"liquid biopsy","rechallenge therapies","Anti-EGFR","2026-04-15",{"date":302,"type":36},"2026-04-17",{"date":304,"type":36},"2024-03-01",{"date":306,"type":22},"2026-09-01",{"name":308,"class":72},"Niguarda Hospital",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":73},"100596225","phase-2-trial-of-5-fluorouracil-5fu-based-therapy-in-combination-with-fruquintinib-in-patients-with-locally-advanced-unresectable-or-metastatic-colorectal-cancer-100596225","NCT07042685","Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Male or female ≥18 years of age.\n2. Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period.\n3. Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer. The study will include an all-comer population, meaning that patients will not be excluded based on specific molecular markers such as microsatellite instability-high (MSI-H) or B-Raf proto-oncogene mutations (BRAF mutations). However, as part of the Standard of Care, comprehensive molecular testing will be performed to assess MSI status, and other relevant biomarkers. For patients with MSI-H or BRAF mutations confirmed, treatment may be adjusted per Standard of Care practices.\n4. Measurable disease per RECISTv1.1.\n5. No prior systemic treatment. Patients with resected disease who later develop unresectable recurrence without prior systemic therapy remain eligible.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy ≥6 months per treating physician's assessment.\n8. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.\n9. Patients must be able to swallow oral tablets.\n\nExclusion Criteria:\n\n1. Hematology laboratory values of:\n\n   1. Absolute neutrophil count ≤1500 cells\u002Fmm3\n   2. Platelets ≤100,000 cells\u002Fmm3\n   3. Hemoglobin ≤9 g\u002FdL\n   4. White blood count ≤3000 cells\u002Fmm3.\n2. Hepatic laboratory values of aspartate transaminase (AST) or alanine aminotransferase (ALT):\n\n   1. \\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or\n   2. \\>2.5 × ULN if no liver metastases are present.\n3. Serum albumin \\\u003C2.8 g\u002FdL.\n4. Total bilirubin \\>1.7 mg\u002FdL × ULN.\n5. Prothrombin time (PT) or international normalized ratio (INR) \\>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.\n6. Serum creatinine or serum urea \\>1.5 × ULN.\n7. Estimated glomerular filtration rate \\\u003C50 mL\u002Fmin.\n8. Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g\u002F24-h. Subjects with 1+ proteinuria must undergo a 24-hour urine collection to assess urine protein level.\n9. Positive pregnancy test, pregnant, or breastfeeding for all women of child-bearing potential.\n10. Per treating physician's assessment, any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.\n11. Any clinically significant and\u002For uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:\n\n    1. Arrhythmia\n    2. Bradycardia\n    3. Tachycardia\n    4. Symptomatic valvular disease\n    5. Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV\n    6. Unstable angina pectoris.\n12. Myocardial infarction within the past 6 months from consent.\n13. Active bleeding diathesis.\n14. Current complaints of persistent constipation or history of chronic constipation, untreatable bowel obstruction, or fecaloma within the past 6 months from consent.\n15. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other systemic immunosuppressive agents. Topical or nasal corticosteroids are allowed.\n16. Known history and\u002For uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.\n17. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.\n18. History of malignancy or active treatment for malignancy other than CRC (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.\n19. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month from consent. Note: Influenza vaccine will be allowed if administered \\>21 days.\n20. Receipt of any investigational agent or study treatment within the past 30 days from consent for a condition other than CRC.\n21. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months from consent for a condition other than CRC.\n22. Uncontrolled hypertension\n23. Active infection requiring treatment\n24. Recent history of major surgery\n25. Thromboembolic events during the past 6 months\n26. Adults unable to consent\n27. Prisoners",{"count":317,"type":22},50,[55],"This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.",[28],[322,130,323],"first line","metastatic","2026-04-08",{"date":326,"type":36},"2026-04-09",{"date":328,"type":36},"2026-01-27",{"date":330,"type":22},"2029-12",{"name":332,"class":72},"The Methodist Hospital Research Institute",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":73},"100631733","phase-1-personalized-t-cell-therapy-ineo-vac-t01-in-advanced-colorectal-cancer-100631733","NCT07504523","Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer","Evaluation of Feasibility, Safety, and Efficacy of Tumor Neoantigen-Based Personalized T-Cell Therapy iNeo-Vac-T01 in Patients With Advanced Colorectal Cancer","Inclusion Criteria\n\n1. Aged ≥ 18 years and ≤ 70 years;\n2. Patients with pathologically and radiologically confirmed advanced colorectal cancer, with at least one measurable lesion on imaging;\n3. Failure of standard therapy, ineligibility for standard therapy, or refusal to receive standard therapy;\n4. Expected survival of at least 6 months;\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n6. Sufficient tumor tissue sample available for genomic analysis, or existing whole-genome\u002Fwhole-exome\u002Ftranscriptome sequencing data of tumor and normal tissues that meet analytical requirements;\n7. Normal function of major organs including heart, liver, and kidney;\n8. Normal hematological parameters:\n\n   Neutrophil count ≥ 1.5 × 10⁹\u002FL Hemoglobin ≥ 10 g\u002FdL Platelet count ≥ 100 × 10⁹\u002FL\n9. Normal biochemical parameters:\n\n   Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ≤ 3 × ULN allowed in patients with liver metastasis AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN allowed in patients with liver metastasis Serum creatinine and blood urea nitrogen (BUN) ≤ 1.5 × ULN\n10. For women of childbearing potential:\n\n    negative pregnancy test within 7 days before enrollment, no intention to become pregnant in the near term, and willingness to use effective contraception during the study; Pregnant or lactating women are excluded.\n11. Male patients willing to use appropriate contraceptive measures;\n12. Ability to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria\n\n1. Unwilling to sign the informed consent form.\n2. Concurrent malignancy other than the following:\n\n   cured basal cell carcinoma, thyroid cancer, cervical dysplasia, and disease-free for more than 5 years with low risk of recurrence in the investigator's judgment.\n3. No actionable neoantigens identified for personalized immunotherapy after sequencing data analysis.\n4. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.\n5. Concomitant use of any other anticancer drugs, investigational anticancer therapy, or immunosuppressive agents; long-term use of systemic glucocorticoids.\n6. Symptomatic or untreated known brain metastasis or other central nervous system (CNS) metastases.\n\n   Patients with completely resected and\u002For irradiated CNS metastases that are stable or improved (radiologically stable for at least 4 weeks prior to randomization by CT\u002FMRI, no evidence of cerebral edema, and no requirement for glucocorticoids or anticonvulsants) are eligible.\n7. Received other vaccinations within 4 weeks prior to treatment (except COVID-19 vaccine).\n8. Clinically confirmed active bacterial or fungal infection; active tuberculosis or history of tuberculosis.\n9. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the normal range; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.\n10. Severe asthma, autoimmune disease, or immunodeficiency requiring immunosuppressive therapy.\n\n    Excluded: vitiligo, type 1 diabetes, autoimmune hypothyroidism controlled by hormones, psoriasis not requiring systemic therapy.\n11. Known history of primary immunodeficiency.\n12. History of psychiatric disorder.\n13. Uncontrolled comorbidities including but not limited to:\n\n    active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia; severe coronary artery disease or cerebrovascular disease; or other conditions deemed ineligible by the investigator.\n14. Substance abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study.\n15. History of severe allergy to food, drugs, or vaccines, or other potential allergy to immunotherapy in the investigator's judgment.\n16. Patients considered ineligible by the investigator or unlikely to complete the study for other reasons.","70 Years",{"count":342,"type":22},20,[83],"The primary objective of this study is to evaluate the feasibility, safety, and efficacy of personalized T-cell therapy based on tumor neoantigens in patients with advanced colorectal cancer, so as to provide a novel individualized therapeutic strategy for such patients.",[28],"2026-03-26",{"date":348,"type":36},"2026-04-01",{"date":350,"type":36},"2023-11-01",{"date":352,"type":22},"2027-12-31",{"name":354,"class":72},"Ying Yuan, MD",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":373,"locationsCount":4},"100631540","phase-2-a-clinical-study-of-iparomlimab-and-tuvonralimab-combined-with-fruquintinib-and-heterogeneous-radiotherapy-versus-fruquintinib-as-third-line-and-subsequent-line-treatment-for-metastatic-colorectal-cancer-100631540","NCT07502014","A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer","A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Patients aged 18 to 75 years (inclusive).\n* Histologically or cytologically confirmed stage Ⅳ primary colorectal cancer.\n* No more than 5 oligometastatic lesions, with metastases usually limited to one or a few specific organs (e.g., liver, lung, etc.), and the metastatic lesions are deemed suitable for stereotactic body radiation therapy (SBRT) by the investigator.\n* Failure of at least 2 prior lines of standard therapy (based on fluorouracil, oxaliplatin, irinotecan, bevacizumab, cetuximab).\n\nNote: Adjuvant\u002Fneoadjuvant therapy is permitted. If recurrence occurs during adjuvant\u002Fneoadjuvant therapy or within 6 months after its completion, the adjuvant\u002Fneoadjuvant therapy will be regarded as the first-line therapy for advanced disease.\n\n* At least one extracranial measurable lesion meeting the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Prior radiotherapy is permitted, but it must be more than 4 weeks before study enrollment. In addition, the lesions selected for radiotherapy and evaluable lesions in this study must be untreated with radiotherapy, and the prior radiotherapy must not affect the normal tissue dose of radiotherapy in this study. (Note: If radiotherapy was received before enrollment, detailed radiotherapy-related parameter data must be provided.)\n* If a subject has undergone surgery, he\u002Fshe must have fully recovered from the toxicities and complications of the surgical intervention before the start of treatment, and enrollment will be considered only after the wound is completely healed.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Expected survival of ≥12 weeks.\n* Adequate function of major organs (no use of any blood components or cell growth factors within 2 weeks before enrollment), meeting the following requirements:\n\n  1. Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, white blood cell (WBC) count ≥4.0×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL.\n  2. Hepatic function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN). If serum total bilirubin level \\>1.5×ULN, direct bilirubin level must be ≤ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (up to 5×ULN for patients with liver metastases).\n  3. Renal function: Blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5×ULN (with creatinine clearance rate (CCr) ≥50 mL\u002Fmin).\n  4. Cardiac function: Normal cardiac function with left ventricular ejection fraction (LVEF) ≥50%.\n  5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Male or female patients of childbearing potential must voluntarily use effective contraceptive methods during the study and within 6 months after the last study drug administration, such as double barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered of childbearing potential unless they have natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy, ovarian irradiation, etc.).\n\nExclusion Criteria:\n\n* Prior treatment with anti-PD-1\u002FPD-L1, anti-CTLA-4 agents, or other investigational immunotherapeutic agents.\n* Severe autoimmune diseases, including active inflammatory bowel disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis.\n* Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.\n* History of other malignancies; however, patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast may be enrolled.\n* Patients planning to undergo or having previously received organ or allogeneic bone marrow transplantation.\n* Clinically significant moderate to severe ascites requiring therapeutic paracentesis or drainage, or Child-Pugh score \\>2 (except for radiologically detected minimal ascites without clinical symptoms); uncontrolled moderate or large pleural effusion or pericardial effusion.\n* History of gastrointestinal bleeding or definite bleeding tendency within 6 months prior to initiation of study treatment, including: high-risk or severe esophagogastric varices, active local peptic ulcer lesions, persistent positive fecal occult blood test. (Patients with positive baseline fecal occult blood may be retested; if still positive, esophagogastroduodenoscopy (EGD) is required. Patients with EGD evidence of bleeding-risk varices are excluded.)\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.\n* Known congenital or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency such as hemophilia; currently using or having recently used (within 10 days before study treatment) full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes. (Prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted.)\n* Currently using or having recently used (within 10 days before study treatment) aspirin (\\> 325 mg\u002Fday, maximal antiplatelet dose), dipyridamole, ticlopidine, clopidogrel (≥75 mg), or cilostazol.\n* Thrombotic or embolic events within 6 months prior to initiation of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n* Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia.\n* Any physical or clinical laboratory abnormality that, in the investigator's opinion, may interfere with study outcomes or increase the risk of treatment complications, or other uncontrolled medical conditions.\n* Patients requiring urgent palliative radiotherapy or emergency surgery (spinal cord compression, cerebral herniation, pathological fracture) as judged by the investigator.\n* Breastfeeding or pregnant female patients.\n* Congenital or acquired immunodeficiency disorders including human immunodeficiency virus (HIV) infection, or history of organ transplantation or allogeneic stem cell transplantation.\n* Patients with psychiatric disorders, substance abuse, or social issues affecting compliance, as determined by the treating physician.\n* Active infection including active tuberculosis is excluded. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection may be enrolled if disease is stable following antiviral therapy.\n* Administration of live attenuated vaccines within 30 days prior to enrollment. (Note: Injectable seasonal influenza vaccines are mostly inactivated and permitted; intranasal formulations are usually live attenuated and prohibited.)\n* Poorly controlled cardiac symptoms or diseases including:\n\n  1. New York Heart Association (NYHA) Class ≥II cardiac insufficiency or LVEF \\\u003C50% on echocardiography;\n  2. Unstable angina;\n  3. Myocardial infarction within 1 year prior to initiation of study treatment;\n  4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;\n  5. QTc interval \\>450 ms (males) or \\>470 ms (females) calculated by Fridericia formula. (If QTc is abnormal, three consecutive measurements at 2-minute intervals may be performed and averaged.)\n* Hypertension not adequately controlled by antihypertensive therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, based on average of ≥2 measurements). History of hypertensive crisis or hypertensive encephalopathy.\n* Major vascular disease within 6 months prior to initiation of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).\n* Severe, non-healing or dehiscent wound, active ulcer, or untreated fracture.\n* Major surgery (except diagnostic procedures) within 4 weeks prior to initiation of study treatment, or expected major surgery during the study period.\n* Inability to swallow tablets, malabsorption syndrome, or any condition impairing gastrointestinal absorption.\n* History of intestinal obstruction or clinical signs\u002Fsymptoms of gastrointestinal obstruction within 6 months prior to initiation of study treatment, including partial obstruction related to underlying disease requiring parenteral hydration, parenteral nutrition, or tube feeding.\n* Patients presenting with partial obstruction, obstruction syndrome, or signs\u002Fsymptoms of ileus at initial diagnosis may be enrolled if they received definitive (surgical) treatment resulting in resolution of symptoms.\n* Evidence of intra-abdominal free air not explained by recent paracentesis or surgery.\n* Metastatic disease involving major airways or vessels (e.g., complete occlusion of main portal vein or vena cava due to tumor invasion is excluded; main portal vein is defined as the confluence of splenic and superior mesenteric veins and its bifurcation into right and left intrahepatic branches) or large central mediastinal mass (\\\u003C30 mm from carina).\n* History of hepatic encephalopathy.\n* Current interstitial pneumonitis or interstitial lung disease; history of interstitial pneumonitis or lung disease requiring corticosteroid treatment; pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonitis, idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT with severely impaired pulmonary function. (History of radiation pneumonitis in radiation field is permitted.) Active tuberculosis.\n* Active autoimmune disease or history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Patients with controlled hypothyroidism requiring only hormone replacement may be enrolled. Patients with skin diseases not requiring systemic therapy (vitiligo, psoriasis, alopecia), controlled type 1 diabetes mellitus on insulin, or childhood asthma in complete remission without adult intervention may be enrolled. Asthma requiring medical intervention with bronchodilators is excluded.\n* Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for immunosuppressive purposes within 14 days prior to initiation of study treatment.\n* Known severe hypersensitivity to any monoclonal antibody or anti-angiogenic targeted therapy.\n* Seere infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment. (Patients receiving prophylactic antibiotics are eligible.)\n* Patients with any other conditions that, in the investigator's judgment, may affect study outcomes or lead to premature discontinuation, such as alcoholism, drug abuse, other severe comorbidities (including psychiatric disorders), significant laboratory abnormalities, or family\u002Fsocial issues compromising patient safety, will be excluded.",{"count":363,"type":22},60,[55],"This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.",[28,30],"2026-03-24",{"date":369,"type":36},"2026-03-30",{"date":371,"type":22},"2026-05-01",{"date":281,"type":22},{"name":374,"class":72},"Huazhong University of Science and Technology",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":4},"100623317","phase-2-a-clinical-study-on-the-treatment-of-metastatic-colorectal-cancer-at-the-second-line-or-beyond-100623317","NCT07395063","A Clinical Study on the Treatment of Metastatic Colorectal Cancer at the Second-line or Beyond.","A Single-arm, Open-label Clinical Study of Irinotecan Liposome Combined With Capecitabine, Bevacizumab and Camrelizumab as Second-line or Higher Treatment for Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Patients pathologically diagnosed with colorectal cancer;\n* Received systemic treatment on the first line;\n* Age: 18 to 75 years old, gender not limited.\n* There must be at least one measurable lesion as the target lesion (in accordance with the RECIST v1.1 standard);\n* ECOG: 0-1;\n* Expected survival period ≥3 months;\n* Women of childbearing age must undergo a blood pregnancy test within 3 days before randomization, and the result must be negative. They must also be willing to take appropriate contraceptive measures during the trial and for 6 months after the end of treatment. For men, it should be agreed to use appropriate methods of contraception during the study period and within 3 months after the end of treatment;\n* The subjects voluntarily joined this study and signed the informed consent form.\n\nExclusion Criteria:\n\n* Patients with wild-type RAS and BRAF, whose primary lesion is located in the left colorectal tract, but who have not received cetuximab as the first-line treatment\n* Patients with advanced colorectal cancer who have MSI-H or dMMR\n* Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ\n* For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication\n* Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months\n* Those who need immunosuppressive therapy for organ transplantation\n* Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases\n* The baseline blood routine and biochemical indicators of the subjects did not meet the following criteria: hemoglobin ≥90g\u002FL; The absolute neutrophil count (ANC) is ≥1.5×109\u002FL; Platelet count ≥100×109\u002FL; ALT and AST≤2.5 times the normal upper limit value; ALP≤2.5 times the normal upper limit value; Serum total bilirubin \\\u003C1.5 times the normal upper limit value; Serum creatinine \\\u003C1 times the upper limit of normal; Serum albumin ≥30g\u002FL\n* Those known to have a deficiency of dihydropyrimidine dehydrogenase (DPD)\n* Those who are allergic to any investigational drug ingredients (such as irinotecan, irinotecan liposome, capecitabine, bevacizumab and camrelizumab)\n* Pregnant or breastfeeding women\n* Have received any of the following treatments:\n\nThe concomitant medication contained CYP3A4, CYP2C8 strong suppressor\u002Fstrong inducer or UGT1A1 strong suppressor within 2 weeks prior to randomization;Use immunosuppressants or systemic hormones for immunosuppressive purposes within 2 weeks before randomization (dose \\>10mg\u002F day, prednisone or other equivalent therapeutic hormones); \\\u003Cs:1\\> Received radiotherapy within 2 weeks prior to randomization;Undergo major surgeries (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization;The patient has received any other clinical study drug treatment within 4 weeks prior to randomization, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study.\n\n\\- Abnormal coagulation function, with a bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg\u002F day) and low-molecular-weight heparin (enoxaparin 40mg\u002F day and other low-molecular-weight heparin at equivalent doses) is permitted.",{"count":383,"type":22},68,[55],"A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer The medication regimen is irinotecan liposome (II) + capecitabine + bevacizumab + camrelizumab until disease progression or intolerable toxicity.",[28],[388,389],"Metastatic colorectal cancer of stage ll or higher","The treatment regimen of irinotecan liposome combined with capecitabine and camrelizumab","2026-02-03",{"date":392,"type":36},"2026-02-09",{"date":394,"type":22},"2026-02-01",{"date":396,"type":22},"2029-02-01",{"name":398,"class":72},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100622295","phase-2-romance-irinotecan-plus-cetuximab-rechallenge-versus-trifluridinetipiracil-plus-bevacizumab-in-molecularly-selected-metastatic-colorectal-cancer-100622295","NCT07381764","ROMANCE: \"Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine\u002FTipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer\"","ROMANCE GOIM Study: A Phase II, Open Label, Multicenter Trial Investigating Irinotecan Plus Cetuximab Rechallenge Compared With Trifluridine\u002FTipiracil Plus Bevacizumab as Third Line Treatment in Circulating Tumor DNA Molecularly Selected Metastatic Colorectal Cancer","ROMANCE - GOIM","Inclusion Criteria:\n\n1. Male or female aged ≥18 years\n2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1\n3. Diagnosis of histologically or cytologically confirmed colorectal cancer.\n4. At least one measurable lesion according to RECIST1.1\n5. KRAS\u002FNRAS\u002FBRAFV600E wt status of primary CRC or related metastasis (local laboratory assessment).\n6. Progression to previous first-line anti-EGFR-containing therapy producing at least a partial response ≥ 6 months.\n7. Received and progressed to an anti-EGFR and irinotecan free second-line treatment.\n8. Have an anti-EGFR free interval of at least 4 months.\n9. Refractory to previous 5-fluorouracil\u002Fcapecitabine, irinotecan, oxaliplatin, bevacizumab.\n10. RAS\u002FBRAF\u002FEGFR\u002FPIK3CAex20\u002FMAP2K1\u002FMET WT and HER2 not amplified ctDNA at FoundationOne CDx test at baseline.\n11. Life expectancy of at least 3 months.\n12. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, lymphocyte count ≥ 0.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL (may have been transfused).\n13. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).\n14. Adequate renal function defined by an estimated creatinine clearance \\> 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method).\n15. No contraindication to the study drugs.\n16. No prior treatment with trifluridine\u002Ftipiracil.\n17. Women of childbearing potential\\* must have a negative blood pregnancy test at thescreening visit. Subjects and their partners must be willing to avoid pregnancy during the trial.\n\n    \\*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n18. Women of childbearing potential, or male, must agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate.\n19. Will and ability to comply with the protocol.\n20. Signed informed consent obtained before screening.\n\nExclusion Criteria:\n\n1. ECOG PS ≥2\n2. Received more than 2 lines of treatment for metastatic disease.\n3. Previous treatment with trifluridine\u002Ftipiracil\n4. RAS\u002FBRAF\u002FEGFR\u002FPIK3CAex20\u002FMAP2K1\u002FMET WT HER2 not amplified status at liquid biopsy analysis during screening.\n5. Previous history of malignancy within the last 2 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ\n6. Evidence of bleeding diathesis or coagulopathy.\n7. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.\n8. Known severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).\n9. Clinically significant cardiovascular disease, active inflammatory bowel disease, active autoimmune disease.\n10. Diagnosis of interstitial pneumonitis or pulmonary fibrosis.\n11. History of abdominal fistula, GI perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment.\n12. Pregnant or lactating women.\n13. Psychiatric or addictive disorders would preclude study participation.\n14. Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study treatments.\n15. Withdrawal of the consent to take part to the study.",{"count":408,"type":22},150,[55],"This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine\u002Ftipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine\u002Ftipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.",[28],"2026-01-26",{"date":414,"type":36},"2026-02-02",{"date":369,"type":22},{"date":417,"type":22},"2031-03-30",{"name":419,"class":72},"Gruppo Oncologico Italia Meridionale",26,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":440,"locationsCount":73},"100614984","phase-2-fruquintinib-combined-with-trifluridinetipiracil-versus-bevacizumab-combined-with-trifluridinetipiracil-for-advanced-metastatic-colorectal-cancer-100614984","NCT07286695","Fruquintinib Combined With Trifluridine\u002FTipiracil Versus Bevacizumab Combined With Trifluridine\u002FTipiracil for Advanced Metastatic Colorectal Cancer","A Multicenter, Open-label, Randomized Controlled Study of Fruquintinib Combined With Trifluridine\u002FTipiracil Versus Bevacizumab Combined With Trifluridine\u002FTipiracil in the Treatment of Patients With Advanced Metastatic Colorectal Cancer Who Failed Standard Chemotherapy","Inclusion Criteria:\n\n* Have a full understanding of this study and voluntarily sign the informed consent form;\n* Aged 18-75 years old (including 18 and 75 years old);\n* Diagnosed with advanced metastatic colorectal adenocarcinoma by histopathological examination;\n* Patients who have previously received first-line oxaliplatin and irinotecan treatment, or have received and failed at least two lines of standard chemotherapy regimens. These standard treatment regimens must include fluoropyrimidine-based drugs, oxaliplatin and irinotecan (with or without bevacizumab or cetuximab). Treatment failure is defined as disease progression occurring during treatment or within 3 months after the last treatment, or intolerable toxic side effects. Each line of treatment must include one or more chemotherapy drugs administered for ≥1 cycle; if recurrence or metastasis occurs during adjuvant\u002Fneoadjuvant treatment or within 6 months after completion of adjuvant\u002Fneoadjuvant treatment, the adjuvant\u002Fneoadjuvant treatment is considered a failure of first-line chemotherapy for advanced disease;\n* Have previously received bevacizumab treatment;\n* Must have at least one clear measurable lesion that meets the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n* ECOG performance status of 0-1;\n* Expected survival time ≥12 weeks;\n* Within 7 days before enrollment, the function of important organs must meet the following requirements (the use of any blood components and cell growth factors within 14 days before enrollment is not allowed):\n\nAbsolute neutrophil count ≥1.5×10⁹\u002FL; Platelets ≥80×10⁹\u002FL; Hemoglobin ≥8g\u002FdL; Total bilirubin ≤1.5×ULN (upper limit of normal); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤2.5×ULN (for patients with liver metastasis, ≤5×ULN); Serum creatinine ≤1.5×ULN, and estimated glomerular filtration rate ≥50ml\u002Fmin; International Normalized Ratio (INR) ≤1.5 or activated partial thromboplastin time (APTT) ≤1.5×ULN;\n\n• Good compliance and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Unable to comply with the study protocol or procedures;\n* Previous treatment with TAS-102 or vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) (e.g., anlotinib, apatinib, etc.);\n* Participation in other drug clinical trials within 4 weeks before enrollment;\n* Have received or is currently receiving other systemic anti-tumor treatments within 4 weeks prior to enrollment;\n* Patients with currently uncontrolled hypertension (defined as systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg) despite medication;\n* Patients with current diseases or conditions that affect drug absorption, or patients unable to take oral medications;\n* Patients with active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, active bleeding from unresected tumors, or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation;\n* History of arterial thrombosis or deep vein thrombosis within 6 months before enrollment;\n* Patients with evidence or medical history of significant bleeding tendency within 2 months before enrollment, such as melena, hematemesis, hemoptysis, fecal occult blood test (FOBT) result of ++ or above (for patients with FOBT result of + and existing primary lesions, gastroscopy must be performed to rule out bleeding or ulcers before enrollment);\n* History of stroke and\u002For transient ischemic attack within 12 months before enrollment; presence of cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure of New York Heart Association (NYHA) class \\>2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) \\\u003C50% (confirmed by echocardiography);\n* History of other malignant tumors within the past 5 years, except for fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of organs such as the cervix, early non-invasive lung cancer, and non-muscle-invasive bladder cancer;\n* Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (for patients with a history of hepatitis B virus infection, regardless of medication control, hepatitis B virus DNA ≥1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL);\n* Pregnant women (positive pregnancy test before medication administration) or lactating women;\n* Urinalysis showing urine protein ≥2+, or 24-hour urine protein quantitation \\>1.0g;\n* Patients deemed unsuitable for enrollment in this study by the investigator.",{"count":429,"type":22},292,[55],"Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with chemotherapy. Trifluridine\u002Ftipiracil plus bevacizumab is also a standard treatment for mCRC. This study aims to explore the efficacy and safety of fruquintinib combined with trifluridine\u002Ftipiracil versus bevacizumab combined with trifluridine\u002Ftipiracil in the treatment of patients with advanced metastatic colorectal cancer who failed standard chemotherapy.",[28,433],"Colorectal Cancer","2026-01-18",{"date":436,"type":36},"2026-01-21",{"date":438,"type":22},"2025-12-31",{"date":281,"type":22},{"name":441,"class":72},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":73},"100616721","phase-3-nalirifox-plus-targeted-therapy-versus-folfox-plus-targeted-therapy-as-first-line-treatment-for-metastatic-colorectal-cancer-100616721","NCT07309289","NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer","NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial","Inclusion Criteria:\n\n* ≥18 years old\n* Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma\n* The unresectable stage of metastatic disease has not received any systemic antitumor therapy\n* For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy\n* The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria\n* ECOG 0\\~1\n* Normal bone marrow and organ function\n* Understand the situation of this study, patients and\u002For legal representatives voluntarily agree to participate in this study and sign informed consent form\n\nExclusion Criteria:\n\n* Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors.\n* Patients allergic to the investigational drug and its excipients\n* Underweight (body mass index \\[BMI\\]\\\u003C18.5 kg\u002Fm\\^2\n* Known or suspected central nervous system metastasis\n* Received irinotecan before enrollment\n* Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment\n* Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 class I or below.\n* The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment\n* Serious gastrointestinal disorders\n* Interstitial lung disease\n* Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding)\n* Patients with fluid accumulation that couldn't reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled\n* Intestinal obstruction, or a risk of intestinal obstruction in the short term\n* Gastrointestinal perforation, intraperitoneal abscess, and fistula\n* Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc\n* Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer\n* Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding\n* The researchers didn't consider it appropriate to participate in this study",{"count":450,"type":22},144,[25],"To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.",[28],"2025-12-28",{"date":456,"type":36},"2025-12-30",{"date":458,"type":36},"2025-07-01",{"date":460,"type":22},"2029-09-01",{"name":462,"class":72},"Shanghai Zhongshan Hospital",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":73},"100610920","phase-2-a-phase-ii-clinical-study-evaluating-ssgj-706-in-combination-therapy-for-advanced-gastrointestinal-cancers-100610920","NCT07233850","A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers","Inclusion Criteria:\n\n1. Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF).\n2. Age 18-75 years old, male or female.\n3. Has a life expectancy of at least 3 months\n4. ECOG score of 0-1.\n5. Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric\u002Fgastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer.\n6. No prior systemic therapy in the locally advanced unresectable\u002Fmetastatic setting.\n7. Has at least 1 measurable lesion per RECIST version 1.1.\n8. Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample).\n9. Has bone marrow, kidney, liver, blood and clotting test results required per protocol.\n10. Female subjects of childbearing age had a negative serum pregnancy test within 7 days before the first dose. Male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until at least 120 days after the last use of study drug and for at least 180 days after the last use of chemotherapy drugs or bevacizumab. During this period, women are not lactating, male subjects are not allowed to freeze or donate sperm, and female subjects are not allowed to donate eggs or retrieve eggs for personal use.\n\nExclusion Criteria:\n\n1. For gastric\u002Fgastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).\n2. For colorectal cancer: Patients with known MSI-H or dMMR.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.\n4. Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases (such as surgery, radiotherapy) are allowed to enroll if they are clinically stable for at least four weeks after treatment (until the first dose of study drug) and corticosteroids are discontinued 3 days before the first dose of study drug; Subjects with untreated, asymptomatic brain metastases can be enrolled.\n5. Previous immunotherapy, including immune checkpoint inhibitors (e.g., PD-l\u002FL1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, OX40 antibody, etc.), immune cell therapy and any other treatment targeting the mechanism of anti-tumor immune action.\n6. Adverse reactions caused by previous anti-tumor therapy need to be restored to grade ≤1 (as judged by NCI-CTCAE 5.0 criteria), except for alopecia and fatigue.\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n8. Prior or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy.\n9. History of severe bleeding tendency or coagulation dysfunction.\n10. Presence of gastrointestinal perforation and\u002For fistula, intra-abdominal abscess within 6 months before the first dose.\n11. Subjects with known active tuberculosis (TB).\n12. Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies.\n13. Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results.",{"count":185,"type":22},[55],"This study is a multicenter, open-label, phase II clinical trial evaluating the combination of SSGJ-706 with standard therapy for advanced gastrointestinal tumors. Its objective is to assess the safety, tolerability, and antitumor activity of SSGJ-706 in combination with standard treatment.",[473,28,474,475],"Gastric\u002FGastroesophageal Junction Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Oesophageal Cancer","2025-11-14",{"date":38,"type":36},{"date":479,"type":22},"2025-11",{"date":481,"type":22},"2027-12",{"name":483,"class":43},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":495,"conditions":496,"keywords":499,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":73},"100605817","early-phase-1-neuroprotective-potential-of-cannabidiol-cbd-in-preventing-oxaliplatin-ox-induced-neuropathy-100605817","NCT07167446","Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy","Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study","Inclusion Criteria:\n\n1. Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).\n2. Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.\n3. ECOG PS 0-2\n4. No prior platinum exposure\n5. No evidence of ongoing neuropathy of any grade at the time of enrollment\n6. Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:\n\n   1. Total Bilirubin: less than and\u002For equal to 1.5 X ULN\n   2. AST(SGOT)\u002FALT(SGPT): less than and\u002For equal to 3 X ULN (5 X ULN in patients with liver metastases\n7. Ability to understand and willingness to sign a written informed consent and HIPAA consent document.\n\n   Exclusion Criteria:\n8. Family history of genetic\u002Ffamilial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to affect cognition, Parkinson's disease, or multiple sclerosis.\n9. Routine use of recreational marijuana products (defined as \\> 4 times per month) or illicit drug use per self-reported history within the last 90 days. If using medical cannabis products, it should be stopped at least 1 week prior to inclusion.\n10. Known underlying liver disease (Child-Pugh B or C) or baseline elevation of total bilirubin greater than and\u002For equal to 1.5 x upper limit of normal based on screening laboratory values.\n11. 1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.\n12. Patients being treated with anti-seizure or anti-psychotic medications. Patients with a prior history of anti-seizure medication use, who have been off treatment for more than 3 months, are eligible. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) is permitted.\n13. Concomitant treatment with strong inducers of CYP3A4 and\u002For strong inducers of CYP2C19.\n14. Underlying history of epilepsy\u002Frecurrent seizure disorder or unexplained seizure within past 6 months.\n15. Patients with current or lifetime diagnosis of schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \\& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)\n16. Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline\n17. Currently taking medications known to be contraindicated with Epidiolex -FDA-approved CBD (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).\n18. Women who are pregnant or breastfeeding, and individuals of any sex who are capable of reproduction and unwilling to use an effective form of birth control (e.g., condoms, diaphragm, birth control pills, or IUD).\n19. Patients may not be receiving any other investigational agents.",{"count":492,"type":22},30,[494],"EARLY_PHASE1","This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) supplementation to prevent oxaliplatin-induced peripheral neuropathy (OIPN) in patients receiving oxaliplatin-based chemotherapy for colorectal cancer (CRC). Participants will be randomized to receive either CBD capsules in addition to standard therapy or standard therapy alone.",[497,28,498],"Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients","Peripheral Neuropathy Due to Chemotherapy",[500,501,502,503],"Oxaliplatin-Induced Peripheral Neuropathy (OIPN)","Cannabidiol (CBD)","Colorectal Cancer (CRC)","Neuroprotection","2025-10-20",{"date":506,"type":36},"2025-10-22",{"date":508,"type":36},"2025-10-14",{"date":510,"type":22},"2028-09-07",{"name":512,"class":72},"Fox Chase Cancer Center",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":531,"locationsCount":73},"100584275","phase-2-5-fluorouracilleucovorin-5fulv-in-combination-with-regorafenib-in-patients-with-metastatic-colorectal-cancer-100584275","NCT06887218","5-Fluorouracil\u002FLeucovorin (5FU\u002FLV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer","Randomized Phase II Trial of 5-Fluorouracil\u002FLeucovorin (5FU\u002FLV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Male or female ≥18 years of age.\n2. Histopathological or cytologically confirmed metastatic CRC.\n3. Failed second-line therapy for metastatic disease.\n4. A minimum of one measurable disease per RECISTv1.1.\n5. ECOG performance status of 0-2.\n6. Life expectancy ≥6 months per treating physician or principal investigator.\n7. Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.\n8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:\n\n   a. Total bilirubin ≤ 10 x the upper limits of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer) c. Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer) d. Serum creatinine ≤ 1.5 x the ULN e. International normalized ratio (INR)\u002F Partial thromboplastin time (PTT) ≤ 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care.\n\n   f. Platelet count ≥100000 \u002Fmm3, hemoglobin (Hb) ≥9 g\u002FdL, absolute neutrophil count (ANC) ≥1500\u002Fmm3. Blood transfusion to meet the inclusion criteria will not be allowed.\n9. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.\n10. Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug as outlined in Appendices 12.2\n11. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.\n12. Subject must be able to swallow and retain oral medication.\n\nExclusion Criteria:\n\n* 1\\. Hematology laboratory values of:\n\n  1. Absolute neutrophil count ≤1000 cells\u002Fmm3\n  2. Platelets ≤70,000 cells\u002Fmm3\n  3. Hemoglobin ≤9 g\u002FdL\n  4. White blood count ≤3000 cells\u002Fmm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:\n\n  \u003C!-- -->\n\n  1. \\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or\n  2. \\>2.5 × ULN if no liver metastases are present. 3. Serum albumin \\\u003C5.8 g\u002FdL. 4. Total bilirubin \\>10 mg\u002FdL. 5. Prothrombin time (PT) or international normalized ratio (INR) \\>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.\n\n     6\\. Serum creatinine or serum urea \\>1.5 × ULN. 7. Estimated glomerular filtration rate \\\u003C50 mL\u002Fmin. 8. Positive pregnancy test, pregnant, or breastfeeding (female patients only). 9. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.\n\n     10\\. Any clinically significant and\u002For uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:\n\n  \u003C!-- -->\n\n  1. Arrhythmia\n  2. Bradycardia\n  3. Tachycardia\n  4. Symptomatic valvular disease\n  5. Symptomatic congestive heart failure is classified by New York Heart Association as Class III or IV\n  6. Unstable angina pectoris. 11. Myocardial infarction within the past 6 months from the consent date. 12. Active bleeding diathesis. 13. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months from the consent date.\n\n     14\\. Known history and\u002For uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 from the consent date.\n\n     15\\. Active or recent (within 3 years) non-colorectal cancer malignancies, except for low-risk, cured cancers (e.g., squamous or basal cell carcinomas, in situ carcinomas, or others deemed non-significant by the investigator).\n\n     16\\. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered \\>21 days.\n\n     17\\. Receipt of any investigation agent or study treatment within the past 30 days.\n\n     18\\. Ongoing infection \\> Grade 2 NCI-CTCAE V5.0. 19. Symptomatic metastatic brain or meningeal tumors. 20. The presence of a non-healing wound, non-healing ulcer, or bone fracture. 21. Major surgical procedure or significant traumatic injury within 28 days before start of study medication 22. Renal failure that requires hemo-or peritoneal dialysis.\n\n  \u003C!-- -->\n\n  1. Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.\n\n     23\\. Uncontrolled hypertension (systolic pressure \\>140 mm Hg or diastolic pressure \\> 90 mm Hg \\[NCI-CTCAE V5.0\\] on repeated measurement) despite optimal medical management.\n\n     24\\. Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.\n\n     25\\. Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent.\n\n     26\\. Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed. All cancer treatments must be completed at least 3 years prior to registration.\n\n     27\\. Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE V5.0 Grade 2 dyspnea).\n\n     28\\. Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.\n\n     29\\. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.\n\n     30\\. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.",{"count":521,"type":22},57,[55],"This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU\u002FLV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting.\n\nPatients will be randomly assigned in a 2:1 ratio between 5FU\u002FLV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab.\n\nArm 1 (Treatment Arm) will consist of the 5FU\u002FLV administered to 38 patients as (LV \\[400 mg\u002Fm² IV over 120 minutes\\], followed by 5FU \\[400 mg\u002Fm² IV bolus then 2400 mg\u002Fm² IV infusion over 46 hours\\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on \u002F1 week off until disease progression, up to 12 cycles of treatment.\n\nArm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg\u002Fm2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.",[28],"2025-08-20",{"date":527,"type":36},"2025-08-27",{"date":529,"type":36},"2025-05-08",{"date":330,"type":22},{"name":332,"class":72},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":73},"100581890","phase-2-second-line-standard-treatment-sequential-tas-102-and-bevacizumab-combined-with-local-treatment-in-advanced-colorectal-cancer-100581890","NCT06856187","Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","TASBEL","Inclusion Criteria:\n\n* Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\n* Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;\n* At least one measurable lesion according to RECIST 1.1 criteria;\n* ECOG Performance Status 0-1;\n* Estimated life expectancy ≥3months;\n* Adequate major organ function;\n* Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n* Allergy to the investigational drug and\u002For its excipients;\n* Pregnant or lactating women;\n* Prior treatment with TAS-102;\n* Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);\n* Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);\n* Serious illness, including but not limited to the following:\n\n  1. Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;\n  2. Known brain and\u002For leptomeningeal metastases;\n  3. Active infection or fever of unknown origin \\> 38.5 ° C ;\n  4. Poorly controlled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;\n  5. Known inherited or acquired bleeding (e.g., coagulopathy)\n  6. Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;\n  7. Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;\n  8. Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (NYHA Class III or IV) within the last 12 months;\n  9. Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;\n  10. There are serious psychological or psychiatric abnormalities that affect the compliance of patients to participate in this clinical study.\n* Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;\n* Inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption;\n* The investigator assessed that it is not appropriate to participate in the study.",{"count":541,"type":22},119,[55],"This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.",[28],[546,547,548,549],"Colorectal cancer","TAS-102","second-line therapy","maintainance therapy","2025-08-05",{"date":552,"type":36},"2025-08-06",{"date":554,"type":36},"2025-02-28",{"date":556,"type":22},"2027-04-30",{"name":558,"class":72},"Fudan University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":579,"locationsCount":73},"100589746","phase-2-node-sparing-short-course-radiotherapy-plus-chemotherapy-bevacizumab-and-pd-1-inhibitor-in-metastatic-pmmrmss-colorectal-cancer-modifi-crc-100589746","NCT06958419","Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR\u002FMSS Colorectal Cancer (MODIFI-CRC)","Node-Sparing Short-Course Radiotherapy Followed by First-Line Chemotherapy Plus Bevacizumab and PD-1 Inhibitor Versus Chemotherapy Plus Bevacizumab Alone in Metastatic pMMR\u002FMSS Colorectal Cancer: A Randomized, Phase II\u002FIII Trial (MODIFI-CRC)","Inclusion Criteria:\n\n* Voluntarily signs a written informed consent form.\n\n  * Aged between 18 and 75 years at the time of enrollment.\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Expected survival of more than 3 months.\n  * Histologically or cytologically confirmed colorectal adenocarcinoma.\n  * Patients must be considered unsuitable for curative surgical resection or local treatment and must not have received prior systemic anti-tumor therapy for recurrent or metastatic disease. Patients with prior neoadjuvant or adjuvant therapy may be enrolled if recurrence or metastasis occurs ≥12 months after the last dose of such treatment.\n  * At least one measurable lesion per RECIST v1.1 that can be accurately measured repeatedly. Note: Brain metastases cannot be used as target lesions.\n  * Able to provide 10-20 unstained tumor tissue FFPE slides from recent biopsy or archival material stored within 3 years. Ten slides will be used for immunohistochemistry and ten for genomic testing (recent biopsy preferred). If samples are of insufficient quality (as determined by the central lab), additional slides may be required. If adequate slides cannot be provided, partial or full waiver may be granted upon approval by the medical monitor.\n  * Agrees to provide tumor tissue and peripheral blood samples during screening and throughout the study for research purposes.\n  * Adequate organ function as defined below:\n  * Hematologic (no use of blood products or growth factors within 7 days prior to treatment):\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  * Platelet count ≥ 100 × 10⁹\u002FL\n  * Hemoglobin ≥ 90 g\u002FL\n  * Renal:\n  * Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (Cockcroft-Gault formula: CrCl = \\[(140 - age) × weight (kg) × 0.85 (if female)\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\])\n  * Urine protein \\\u003C 2+ on dipstick or \\\u003C 1.0 g per 24-hour urine collection\n  * Hepatic:\n  * Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 × ULN\n  * Serum albumin ≥ 28 g\u002FL\n  * Coagulation:\n  * International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n  * Cardiac:\n  * Left ventricular ejection fraction (LVEF) ≥ 50%\n  * Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to initiating study treatment. If the urine test is inconclusive, a serum test must confirm the result. Women of childbearing potential engaging in sexual activity with non-sterilized male partners must agree to use acceptable contraception from screening through 120 days after the last dose of study drug. The decision to discontinue contraception beyond this period should be discussed with the investigator. Periodic abstinence and the rhythm method are not acceptable.\n  * Women of childbearing potential are defined as those who have not undergone surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and have not been postmenopausal (defined as at least 12 consecutive months of amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range).\n  * Highly effective contraception methods are those with a failure rate of \\\u003C1% per year when used consistently and correctly. In addition to barrier methods, hormonal contraception (e.g., oral contraceptives) must also be used.\n  * Willing and able to comply with scheduled visits, treatment procedures, laboratory tests, and other protocol requirements.\n\nExclusion Criteria:\n\n* • Known MSI-H or dMMR status.\n\n  * History of other malignancies within the past 3 years, except for those cured by local treatment, such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or ductal carcinoma in situ of the breast.\n  * Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune agonists (e.g., ICOS, CD40, CD137, GITR, OX40), or immune cell-based therapies targeting tumor immunity.\n  * Prior adjuvant or neoadjuvant therapy targeting EGFR or VEGF\u002FVEGFR pathways (e.g., bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars).\n  * Active CNS metastases. Patients with previously treated brain metastases may be eligible if clinically stable for at least 2 weeks (from the first dose of study drug) and off corticosteroids for at least 3 days prior to treatment. Patients with untreated, asymptomatic brain metastases (no neurologic symptoms, no corticosteroids, and all lesions ≤ 1.5 cm in longest diameter) may enroll but require regular CNS monitoring.\n  * Known brainstem, meningeal, or spinal cord metastases or compression.\n  * Symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.\n  * Prior systemic or local anti-tumor therapy for locally advanced rectal cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy, biologics, or small-molecule targeted therapy.\n  * Receipt of nonspecific immunomodulators (e.g., interleukins, interferons, thymic peptides, TNF) within 2 weeks prior to study treatment (except IL-11 for thrombocytopenia), or anti-tumor traditional Chinese medicine within 1 week prior to study treatment.\n  * Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., with corticosteroids, immunosuppressants, or DMARDs). Replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal\u002Fpituitary insufficiency) is allowed.\n  * History of non-infectious pneumonitis requiring systemic corticosteroids, or current interstitial lung disease.\n  * History of bleeding disorders or coagulopathy; long-term anticoagulation (e.g., atrial fibrillation with CHADS2 score ≥ 2).\n  * Uncontrolled comorbidities including, but not limited to, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric\u002Fsocial conditions impairing protocol compliance or informed consent.\n  * History of myocarditis, cardiomyopathy, or malignant arrhythmias; unstable angina, congestive heart failure, or vascular disease (e.g., aortic aneurysm requiring repair or DVT) requiring hospitalization within 12 months. Other cardiovascular conditions affecting drug safety (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) are excluded.\n  * Within 6 months prior to study treatment: gastroesophageal varices, severe ulcers, unhealed wounds, GI perforation, fistulas, obstruction, intra-abdominal abscess, or acute GI bleeding.\n  * Within 6 months prior to treatment: arterial thromboembolism, venous thromboembolism (grade ≥3, NCI-CTCAE v5.0), TIA, stroke, hypertensive crisis, or hypertensive encephalopathy.\n  * COPD exacerbation within 1 month before study treatment; uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg despite oral medications).\n  * Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n  * Serious infections within 4 weeks before treatment, including those requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic antibiotics within 10 days before treatment (excluding antiviral therapy for hepatitis B or C).\n  * Major surgery or significant trauma within 30 days prior to treatment; minor local surgery within 3 days (excluding PICC line placement).\n  * History of immunodeficiency; HIV antibody positivity; long-term use of systemic corticosteroids or immunosuppressants.\n  * Known active tuberculosis (TB) or suspected active TB not ruled out by clinical evaluation (e.g., sputum testing, chest imaging); known active syphilis.\n  * History of allogeneic organ or hematopoietic stem cell transplantation.\n  * Untreated active hepatitis B infection (HBsAg-positive with HBV DNA \\> 1,000 copies\u002FmL or \\>200 IU\u002FmL); patients with chronic hepatitis B must receive antiviral therapy during the study. Active hepatitis C (HCV antibody-positive with detectable HCV RNA) is also excluded.\n  * Receipt of a live vaccine within 30 days before treatment or planned live vaccination during the study.\n  * Known allergy to any component of the study drugs or history of serious hypersensitivity to monoclonal antibodies.\n  * Known psychiatric disorders, substance abuse, alcoholism, or drug dependence.\n  * Pregnant or breastfeeding women.\n  * Any condition, treatment, or laboratory abnormality that may interfere with study results, prevent full participation, or not be in the participant's best interest.\n  * Local or systemic disease caused by a benign tumor, or tumor-associated conditions causing high medical risk or survival uncertainty (e.g., leukemoid reaction with WBC \\> 20 × 10⁹\u002FL, cachexia with \\>10% weight loss within 3 months prior to screening, or BMI ≤ 18).\n  * Current evidence of significant gastrointestinal obstruction based on clinical or radiographic findings.\n  * History of bleeding disorders or coagulopathy; radiographic evidence of tumor encasing major vessels or showing necrosis\u002Fcavitation that, in the investigator's judgment, may pose bleeding risk; continuous anticoagulation within 10 days prior to first dose.\n  * Tumor invasion of critical organs or vessels (e.g., heart\u002Fpericardium, trachea, esophagus, aorta, or superior vena cava) with risk of complications such as fistulas (e.g., esophagotracheal, esophageal-pleural, or intestinal fistulas).\n  * Presence of free intraperitoneal gas not attributable to recent puncture or local surgical procedure.",{"count":567,"type":22},286,[55,25],"The current standard first-line treatment for metastatic colorectal cancer is chemotherapy combined with targeted therapy, yet the prognosis remains poor. Although combining immunotherapy, anti-angiogenic agents, and chemotherapy has shown some efficacy in MSS\u002FpMMR metastatic patients, progression-free survival (PFS) remains suboptimal. Radiotherapy-particularly high-dose radiotherapy-can enhance tumor antigen release and potentially improve the response of MSS\u002FpMMR colorectal cancer to PD-1 inhibitors. Tumor-draining lymph nodes (TDLNs) are key sites for PD-1-mediated anti-tumor activity, but radiation-induced damage and fibrosis may impair their immune function. Prior studies have reported a remarkable pathologic complete response (pCR) rate of 77.8% using node-sparing radiotherapy in locally advanced rectal cancer. This phase II\u002FIII study aims to evaluate whether node-sparing modified short-course radiotherapy combined with chemotherapy, bevacizumab, and PD-1 blockade can improve objective response rate (ORR) in phase II and progression-free survival (PFS) in phase III, together with treatment tolerance, and overall prognosis in patients with pMMR\u002FMSS metastatic colorectal cancer.",[571,572,28],"Immune Checkpoint Therapy","Radiotherapy","2025-08-04",{"date":575,"type":36},"2025-08-07",{"date":577,"type":36},"2025-05-01",{"date":202,"type":22},{"name":580,"class":72},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":588,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":604},"100583241","phase-1-nelmastobart-in-combination-with-trifluridine-tipiracil-and-bevacizumab-in-metastatic-recurrent-colorectal-cancer-100583241","NCT06873763","Nelmastobart in Combination With Trifluridine\u002F Tipiracil and Bevacizumab in Metastatic\u002F Recurrent Colorectal Cancer","A Single-arm, Phase Ib\u002F2 Study of Nelmastobart in Combination With Trifluridine\u002FTipiracil and Bevacizumab in Metastatic\u002FRecurrent Colorectal Cancer Patients With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy","Inclusion Criteria:\n\nSubjects who participate in the study must meet all of the following inclusion criteria.\n\n1. Adults ≥19 years old at the time of written informed consent\n2. Patients with histologically\u002Fcytologically confirmed metastatic\u002Frecurrent colorectal cancer after failure of, or not eligible for oxaliplatin and irinotecan-based standard anticancer therapy (If a subject had a radical surgery for colorectal cancer followed by adjuvant anticancer therapy, and the disease recurred during the adjuvant anticancer therapy or within 6 months from the end of the adjuvant anticancer therapy, the adjuvant anticancer therapy will be considered primary palliative therapy.)\n3. Subjects with at least one evaluable lesion, or non-measurable but evaluable lesion according to RECIST v1.1\n4. Subjects with ECOG performance status 0-1\n5. Subjects with adequate bone marrow and body organ functions\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n   * Hemoglobin count (Hgb) ≥ 9.0 g\u002FdL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Serum creatinine ≤ ULN x 1.5 or serum creatinine clearance \\> 30mL\u002Fmin\n   * Total bilirubin ≤ 1.5 x ULN (Subjects with biliary obstruction may be enrolled if they meet the criterion after adequate biliary drainage.)\n   * AST and ALT ≤ 3 x ULN in the absence of liver metastasis; or AST and ALT ≤ 5 x ULN in the presence of liver metastasis\n6. Subjects with adequate cardiac function at the screening visit\n\n   * QTc calculated using the Fredericia formula ≤ 480 msec (Those with QTc \\>480 msec may be enrolled if the mean of 3 consecutive QTc measurements is \\\u003C480 msec.)\n7. A negative serum β-HCG test within 14 days prior to IP dosing for women of childbearing potential\n8. Subjects who agree, and are able to use during the study medically reliable methods of contraception as follows\n\n   * To be eligible for enrollment, women of childbearing potential (all women who can have physiological pregnancy during IP treatment and for 6 months after the end of IP treatment unless they use appropriate methods of contraception) must use the following methods of contraception.\n   * Subjects must refrain from any type of sexual intercourse, and persistent abstinence in daily life is recommended. Periodic abstinence (e.g., rhythm method, cervical mucus method, basal body temperature method, etc.) and withdrawal method are not acceptable methods of contraception.\n   * Female sterilization procedures: Bilateral ovariectomy with or without hysterectomy; tubal ligation within 6 weeks prior to enrollment in this study. If the subject is confirmed to have childbearing potential based on the assessment of hormone level, only bilateral ovariectomy will be permitted.\n   * Vasectomized partner (at least 6 months prior to screening). For women who participate in the study, the vasectomized partner must be the only partner during her participation in this study.\n   * Men must use condoms during sexual intercourse during and after IP treatment (for 6 months after the last IP dose).\n9. Life expectancy ≥3 months\n10. Subjects who consent to sampling tumor tissues or collecting tumor tissue samples obtained within 2 years prior to the screening visit\n11. Subjects who, after being fully informed of the study, voluntarily decide to participate in the study, provide written informed consent, and agree to comply with study procedures during the study\n\n    \\[Inclusion criteria for the phase 2 study\\] Subjects who participate in the phase 2 study must meet all of the following criteria.\n12. Subjects with Tumor Proportion Score (TPS) ≥50 based on immunohistochemistry (IHC) at the screening visit\n\nExclusion Criteria:\n\nIndividuals who meet any of the following exclusion criteria will be excluded from the study.\n\n1. Patients who have hypersensitivity to the active ingredient of IP or any of its components (excipients)\n2. Individuals who had cytotoxic chemotherapy within 14 days prior to randomization; treatment with IP in another clinical trial with the elapse of ≤2 weeks from the last dose of that IP or ≤5 folds the half-life of that IP; or treatment with monoclonal antibody therapy within the past 4 weeks\n3. Uncontrolled serious infection\n4. Confirmed PD during treatment with trifluridine\u002Ftipiracil for palliative care or confirmed recurrence within 6 months after the end of such treatment\n5. Individuals requiring high-dose steroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants\n\n   * However, these individuals may be enrolled in the following cases.\n   * Short-term (\\\u003C7 days) use of systemic corticosteroids that are considered standard of care will be allowed.\n   * Subjects requiring intermittent use of bronchodilators, inhalant steroids, or local steroid injections will be allowed.\n   * Replacement therapy (e.g., thyroxine, insulin, physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered as a type of systemic treatment and will be allowed.\n6. Pregnant or lactating women\n7. Individuals with a history of autoimmune disease requiring systemic treatment (i.e., use of disease modifying therapy, corticosteroids, or immunosuppressants) within 2 years prior to the screening visit (However, enrollment will be possible for subjects with vitiligo, psoriasis not requiring systemic treatment, type 1 diabetes mellitus, hypothyroidism stably managed with hormone replacement therapy, Sjogren's syndrome, or resolved pediatric asthma\u002Fatopy.)\n8. Individuals with active central nervous system lesions (radiologically unstable or symptomatic brain lesions). With the exception of patients with meningeal metastasis, individuals who had radiotherapy or surgical treatment may be enrolled if there is evidence that the patient's condition is maintained without steroid therapy and that the disease of the brain lesion has not progressed for ≥4 weeks.\n9. Individuals with a documented history of cerebrovascular events (stroke or transient ischemic attack), unstable angina pectoris, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to the screening visit\n10. Patients with hypertensive encephalopathy or hypertension that is not adequately controlled with antihypertensives\n11. Individuals with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonia; or with active pneumonia based on screening chest X-rays\n12. Individuals who received allogeneic stem cell or solid organ transplants\n13. Individuals who received live attenuated vaccines within 30 days prior to the screening visit. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella\u002F(varicella) zoster, yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccines. Injectable seasonal influenza vaccines are generally killed virus vaccines and will be allowed. However, intranasal influenza vaccines are live attenuated vaccines and will not be allowed.\n14. Individuals with a history of other primary cancers\n\n    * However, enrollment will be possible for the following cancers.\n    * Adequately treated skin cancer (basal cell or squamous carcinoma) that is not melanoma, superficial cervical cancer or stage 1 bladder cancer, completely resected thyroid cancer which did not metastasize and for which all treatment is completed (Scars must have been adequately treated prior to study enrollment).\n    * Treated solid tumor with no evidence of recurrent disease at least 36 months prior to screening\n15. Side effects of prior anticancer therapy that did not recover to Grade ≤1 (with the exception of alopecia)\n16. Individuals who had radiotherapy in an extensive lesion involving ≥30 % of the bone marrow within 4 weeks prior to the screening visit or limited range radiotherapy for palliative care within 2 weeks\n17. Patients who had major surgery within 4 weeks prior to the screening visit or who have not recovered from side effects of surgery\n18. Patients who are unable to take drugs orally or who have a past history, or pathological findings of major gastrointestinal surgery that may affect the absorption of IP\n19. Patients who have evidence of active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)\n\n    * However, enrollment will be possible for the following cases.\n    * Patients with positive hepatitis B surface antigen (HBsAg) may be enrolled if HBV DNA is negative based on a local test.\n    * Patients with positive hepatitis B core antibody (IgG anti-HBc) and a history of HBV infection may be enrolled if HBV DNA is negative.\n    * Patients with positive anti-HCV Ab may be enrolled if HCV RNA is negative.\n20. Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n21. Individuals with medical, psychiatric, or cognitive disorders or impaired ability to understand information, provide prior consent, comply with protocol procedures, or complete the study\n22. Those whom the investigator deems inappropriate for participation in this clinical trial","19 Years",{"count":590,"type":22},52,[83,55],"The objective of this multi-center, single-group, open-label Phase Ib\u002FII study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine\u002Ftipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.",[28,594],"Recurrent Colorectal Cancer","2025-07-08",{"date":597,"type":36},"2025-07-11",{"date":599,"type":36},"2025-06-09",{"date":601,"type":22},"2027-03",{"name":603,"class":43},"STCube, Inc.",5,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":620,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":73},"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":614,"type":22},22,[55],"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.",[618,28,619],"Unresectable Colorectal Cancer","MSI-H\u002FdMMR Colorectal Cancer",[273,130,621],"MSI-H\u002FdMMR","2025-05-28",{"date":624,"type":36},"2025-06-06",{"date":626,"type":22},"2025-06-27",{"date":352,"type":22},{"name":629,"class":72},"Qianfoshan Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":73},"100589844","phase-2-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-envafolimab-combined-with-cetuxima-and-mfolfox6-in-patients-with-mss-rasbraf-wild-type-metastatic-colorectal-cancer-mcrc-100589844","NCT06959693","A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS\u002FBRAF Wild-Type Metastatic Colorectal Cancer (mCRC)","mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS\u002FBRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase Ⅱ\u002FⅢ Trial","Inclusion Criteria:\n\n* Patients are eligible for the study if they meet all of the following criteria:\n\n  1. Prior to enrollment, the participant is required to sign a written informed consent form.\n  2. Participants should be above 18 years，regardless of gender.\n  3. Histopathologically confirmed untreated advanced colorectal adenocarcinoma.\n  4. Tumors with RAS (KRAS, NRAS, HRAS) and BRAF wild-type, MSS phenotype, excluding appendiceal or anal cancer. All listed codons must be wild-type: KRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146) ; NRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146)\n  5. Imaging (enhanced CT\u002FMRI\u002FPET-CT) confirms advanced\u002Fmetastatic colorectal cancer with measurable lesions according to RECIST v1.1.\n  6. No prior systemic therapy for advanced\u002Fmetastatic colorectal cancer, including chemotherapy, EGFR inhibitors (cetuximab, panitumumab), VEGF inhibitors (bevacizumab), and immune checkpoint inhibitors (anti-PD-1\u002FPD-L1\u002FCTLA-4). Adjuvant\u002Fneoadjuvant chemotherapy within 6 months before recurrence\u002Fmetastasis is considered first-line therapy.\n  7. ECOG PS score 0-1.\n  8. Expected survival \\>12 weeks.\n  9. Adequate organ function (without blood component or growth factor use within 14 days):\n\n     Hematology:Neutrophils ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL. Liver\u002Fkidney function: SCr ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin, TBIL ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (≤5×ULN if due to liver metastasis), urine protein \\\u003C2+ (≤1g\u002F24h if ≥2+).\n  10. Normal coagulation, no active bleeding\u002Fthrombosis: INR ≤1.5×ULN, APTT ≤1.5×ULN, PT ≤1.5×ULN.\n  11. Non-surgically sterile women of childbearing potential must use contraception during and 3 months after treatment; serum\u002Furine HCG negative within 7 days before enrollment; not breastfeeding. Non-surgically sterile men must use contraception with partners during and 3 months after treatment.\n  12. Willing participant with good compliance for safety and survival follow-up.\n\n      Exclusion Criteria:\n\n      \\-\n* Patients will be excluded from the study if they meet any of the following exclusion criteria:\n\n  1. Other malignancies in the past or current (excluding cured basal cell carcinoma or cervical carcinoma in situ).\n  2. Current duodenal ulcer, ulcerative colitis, intestinal obstruction, or other GI conditions that may cause bleeding or perforation, as judged by the investigator.\n  3. Patients with symptomatic pleural, peritoneal, or pericardial effusions requiring treatment.\n  4. History of allergy to monoclonal proteins or any component of the study drugs.\n  5. Oral traditional Chinese medicine, immunomodulators within 2 weeks, or radiotherapy within 4 weeks before treatment.\n  6. Thyroid dysfunction that is uncontrolled by medication.\n  7. Uncontrolled hypertension despite receiving optimal treatment (systolic BP\\>150 mmHg or diastolic BP\\>90 mmHg).\n  8. Uncontrolled cardiac conditions: (1) NYHA Class II+ heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant arrhythmias requiring treatment.\n  9. Active autoimmune disease or a history of such diseases.\n  10. Immunosuppressants, systemic, or absorbable topical steroids for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks before enrollment.\n  11. CNS metastases.\n  12. Active infection or unexplained fever\\>38.5°C during screening or before first dose (tumor-related fever is acceptable).\n  13. History or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severe pulmonary dysfunction.\n  14. Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (elevated transaminases not meeting inclusion criteria, HBV DNA≥1000 IU\u002Fml, HCV RNA≥1000 IU\u002Fml).\n  15. Live vaccine administration within 4 weeks before first dose or planned during the study.\n  16. History of psychiatric drug abuse, alcoholism, or drug addiction.\n  17. Pregnant or breastfeeding women, or those planning pregnancy during the trial.\n  18. Any other factor that may lead to premature study discontinuation, as judged by the investigator.",{"count":638,"type":22},590,[55,25],"This is a prospective randomized controlled Phase Ⅱ\u002FⅢ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS\u002FBRAF Wild-Type Metastatic Colorectal Cancer (mCRC)",[28],"2025-04-28",{"date":644,"type":36},"2025-05-06",{"date":646,"type":22},"2025-06-01",{"date":648,"type":22},"2030-06-30",{"name":71,"class":72}]