[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-cancer-metastatic":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,44,66,90,120,145,173,198,223,253,280,301,318,351,383,406,431,454,482,506,531,558,579,592,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053563","phase-2-a-phase-ii-clinical-study-of-multimodal-ablation-combined-with-systemic-drug-therapy-for-advanced-solid-tumors-100053563",false,"NCT06889610","A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to ablation, all hepatic lesions \\\u003C5 cm in diameter; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received pembrolizumab or toripalimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.","ALL","18 Years","80 Years",{"count":21,"type":22},95,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.",[28,29,30],"Triple Negative Breast Cancer Metastatic","Melanoma Metastatic","Colorectal Cancer Metastatic","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2026-03-30",{"date":39,"type":22},"2028-12-30",{"name":41,"class":42},"Fudan University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100607846","early-phase-1-pilot-study-of-an-implantable-microdevice-for-in-situ-evaluation-of-drug-response-in-patients-with-colorectal-liver-metastasis-100607846","NCT07193862","Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis","Inclusion Criteria:\n\n* Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age\n\nNormal organ and marrow function, defined as follows:\n\n* Leukocytes ≥3,000\u002FmcL\n* Absolute neutrophil count ≥1500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* PT≤ 14, PTT≤ 38, INR ≤ 1.\n* Creatinine within normal institutional limits OR clearance ≥60mL\u002Fmin\u002F1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures\n\nMales and females of childbearing potential must agree to use effective contraception starting before the first day of treatment and continuing for at least 3 months (men) or 6 months (women) after implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents of the study, mothers must agree to discontinue breastfeeding for a total of 14 days after the insertion of the microdevice.\n\nExclusion Criteria:\n\nTumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications involved.\n\nPrior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the CLM Extra-hepatic disease or unresectable liver metastasis on baseline imaging",{"count":51,"type":22},10,[53],"EARLY_PHASE1","Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +\u002F- immune-modulating drugs has an impact on the surrounding tissue.",[30],"2026-06-23",{"date":58,"type":35},"2026-06-24",{"date":60,"type":35},"2025-12-10",{"date":62,"type":22},"2028-04-15",{"name":64,"class":42},"Northwell Health",2,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100639415","phase-1-a-phase-ibii-study-of-hdm2017-in-combination-with-standard-of-care-in-advanced-colorectal-cancer-100639415","NCT07621159","A Phase Ib\u002FII Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer","A Phase Ib\u002FII Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent.\n2. Male or female participants with age ≥ 18 years.\n3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.\n4. Be able to provide archived tumor tissue during the screening period.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Life expectancy ≥3 months.\n7. According to RECIST v1.1, participants must have at least one measurable lesion.\n8. Has adequate organ function.\n9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment.\n10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).\n2. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.\n3. Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.\n5. Known weight loss of \\>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.\n6. History of severe esophagogastric varicose vein, severe ulcer, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.\n7. Participants with current imaging or clinical evidence of significant gastrointestinal obstruction.\n8. Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose.\n9. Participants with known active CNS metastasis.\n10. Participants with cardiovascular\u002Fcerebrovascular disorder, symptoms, or manifestations.\n11. Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.",{"count":74,"type":22},120,[76,25],"PHASE1","This is a phase Ib\u002FII clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.",[30],"NOT_YET_RECRUITING","2026-05-27",{"date":82,"type":35},"2026-06-02",{"date":84,"type":22},"2026-07-15",{"date":86,"type":22},"2028-11-01",{"name":88,"class":89},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":96,"targetDuration":98,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":107,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100637253","china-metastatic-liver-cancer-clinical-registry-cohort-database-100637253","NCT07602504","China Metastatic Liver Cancer Clinical Registry Cohort Database","Inclusion Criteria:\n\n1. Patients with histologically or radiologically confirmed metastatic liver cancer.\n2. Age ≥ 18 years.\n3. Patients who have voluntarily signed the informed consent form.\n4. Patients with complete baseline clinical data.\n\nExclusion Criteria:\n\n1. Patients with primary liver cancer (e.g., hepatocellular carcinoma).\n2. Patients with other malignant tumors that may interfere with the evaluation of liver metastasis.\n3. Patients who have previously participated in other interventional clinical trials.\n4. Patients with severe cognitive disorders or communication barriers that prevent informed consent.\n5. Patients with incomplete or missing key clinical data.",{"count":97,"type":22},2000,"10 Years","OBSERVATIONAL","This study is led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close collaboration with multiple participating centers nationwide. The primary objective is to establish a standardized, large-scale clinical cohort database specifically for metastatic liver cancer. By collecting comprehensive data on patient demographics, primary tumor characteristics, systemic therapies, and local interventions, this registry aims to elucidate the clinical patterns and prognostic factors of secondary liver malignancies. This database will serve as a robust platform for conducting high-quality real-world studies and advancing evidence-based clinical research in the management of metastatic liver cancer.",[102,103,104,105,106,30],"Liver Metastases","Metastases to Liver","Liver Cancer","Neoplasms","Liver Diseases",[108],"Liver Metastases; Metastatic Colorectal Cancer","2026-05-16",{"date":111,"type":35},"2026-05-22",{"date":113,"type":22},"2026-06-01",{"date":115,"type":22},"2036-05-31",{"name":117,"class":118},"Anhui Provincial Hospital","OTHER_GOV",3,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":43},"100539178","phase-2-platform-study-of-immunotherapy-combinations-in-colorectal-cancer-liver-metastases-100539178","NCT06300463","Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","Inclusion Criteria:\n\n* Diagnosis of metastatic colorectal adenocarcinoma with liver metastases\n* Participant must be planning to undergo a surgical resection of their liver metastases.\n* Tumor is non-MSI-H\u002FdMMR\n* Presence of measurable disease\n* Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes\n* Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study\n* Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.\n\nExclusion Criteria:\n\n* Not eligible for surgery\n* Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.\n* Previous allogeneic tissue\u002Forgan transplant\n* Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents\n* Participants must not have any contraindications to immune checkpoint inhibitors\n* Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed",{"count":127,"type":22},24,[25],"The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:\n\n* whether these combinations of immunotherapy change the tumor microenvironment in the liver\n* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases\n\nParticipants will be randomly assigned to one of the following:\n\n* Botensilimab and balstilimab\n* Botensilimab, balstilimab, and AGEN1423\n* Botensilimab, balstilimab, and radiation\n\nParticipants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.",[30,102,131],"Colorectal Cancer",[133,134,135],"Botensilimab","Balstilimab","Immunotherapy","2026-05-13",{"date":138,"type":35},"2026-05-15",{"date":140,"type":35},"2024-03-26",{"date":142,"type":22},"2027-12",{"name":144,"class":42},"Weill Medical College of Cornell University",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":43},"100509457","phase-2-technical-feasibility-of-modified-early-post-operative-intraperitoneal-chemotherapy-mepic-100509457","NCT05913674","Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)","Inclusion Criteria:\n\n* Patient's age 18 years or older, both genders.\n* In good general health as evidenced by an ECOG score of 0 or 1.\n* Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (\\\u003C 12 months after primary diagnosis) or metachronous (\\>12 months after the primary diagnosis)\n* Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate. (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +\u002F- biopsy\n* Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC\n* Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed.\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the study duration\n* Hematology: Absolute neutrophil count (ANC) ≥ 1,500\u002F μL; Platelets \\> 75,000\u002F μL.\n* Adequate Renal function Creatinine \\\u003C1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml\u002Fmin.\n* Adequate Hepatic function: Bilirubin less than 1.5mg\u002FdL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg\u002FdL).\n\nExclusion Criteria:\n\nPre-cytoreductive surgery:\n\n* Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement\n* Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery\n* Known allergic reaction or major toxicity to Fluorouracil\n* Contraindications to Fluorouracil, including history of coronary spasm and\u002For known dihydropyrimidine dehydrogenase deficiency\n* Pregnancy\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy.\n\nPost-cytoreductive surgery:\n\n* Patient deemed not medically suitable to receive mEPIC protocol according to surgical team\n* Uncorrected coagulopathy and\u002For thrombocytopenia and\u002For neutropenia\n* Active infection\n* Hemodynamic and \u002F or respiratory compromise\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate IP therapy.",{"count":7,"type":22},[25],"The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms.\n\nThe primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively.\n\nParticipants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg\u002Fm2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg\u002Fm2) on postoperative days 1 and 2.",[155,156,30],"Peritoneal Carcinomatosis","Appendiceal Neoplasms",[158,159,160,161,162,163],"Intraperitoneal chemotherapy","Early post-operative intraperitoneal chemotherapy","Fluorouracil","Hyperthermic intraperitoneal chemotherapy","Cytoreductive surgery","mEPIC","2026-05-12",{"date":166,"type":35},"2026-05-14",{"date":168,"type":35},"2026-05-01",{"date":170,"type":22},"2028-09",{"name":172,"class":42},"Ciusss de L'Est de l'Île de Montréal",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":43},"100486204","phase-1-in-vivo-lung-perfusion-ivlp-for-colorectal-cancer-metastatic-to-lung-100486204","NCT05611034","In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung","In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers","Inclusion Criteria:\n\n1. Diagnosis of Colorectal Carcinoma\n2. Presence of bilateral pulmonary metastases\n3. 3 or more lung lesions in total\n4. Age 70 years or less\n5. ECOG 0-2\n6. Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment.\n\nExclusion Criteria:\n\n1. Patient has previously received more than 1000 mg of oxaliplatin\n2. Left Ventricular Ejection Fraction \\\u003C50%\n3. History of significant pulmonary disease or pneumonitis\n4. Pregnant or lactating females\n5. Age 71 or older, or less than 18 years\n6. Inability to understand the informed consent process\n7. Hypersenstivity to oxaliplatin\n8. Patients with Heparin-induced thrombocytopenia (HIT)\n9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or another reason can be included but will not receive the drug they cannot tolerate\n10. Current participation in another therapeutic clinical trial","70 Years",{"count":51,"type":22},[76],"This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.",[185,30,131],"Lung Metastases",[187,188],"IVLP","metastatic","2026-04-28",{"date":191,"type":35},"2026-04-29",{"date":193,"type":35},"2023-02-06",{"date":195,"type":22},"2032-01-01",{"name":197,"class":42},"University Health Network, Toronto",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":43},"100561412","phase-2-tl938-and-trastuzumab-for-patients-with-her2-positive-metastatic-colorectal-cancer-100561412","NCT06589830","TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer","A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age 18 years old and above, male or female;\n2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;\n3. At least one measurable lesion;\n4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;\n5. A minimum life expectancy of \\>3 months;\n6. Adequate bone marrow reserve, hepatic, renal, and coagulation function;\n7. Other inclusion criteria apply for participating in the Study. -\n\nExclusion Criteria:\n\n1. Prior anti-HER2 targeting therapy;\n2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \\>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;\n3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);\n4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;\n5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;\n6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;\n7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;\n8. Any active infection which has not been controlled at screening;\n9. Other exclusion criteria apply for participating in the Study. -",{"count":206,"type":22},80,[25],"This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.",[30,210],"Advanced Colorectal Cancer",[212,213,131,214],"Oncology","TL938","HER2","2026-04-22",{"date":189,"type":35},{"date":218,"type":35},"2025-05-13",{"date":220,"type":22},"2027-10",{"name":222,"class":89},"Suzhou Teligene Ltd.",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":43},"100635238","phase-2-balbotagent-797-in-pmmr-crc-with-liver-metastases-100635238","NCT07550088","BAL\u002FBOT\u002FagenT-797 in pMMR CRC With Liver Metastases","A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases","Inclusion Criteria:\n\n* Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally\n* At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver\n* Tumor confirmed as microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR)\n* Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated\n* ECOG performance status 0-1 and life expectancy ≥12 weeks\n* Adequate organ and marrow function:\n\n  * ANC ≥1.5 × 10⁹\u002FL\n  * Platelets ≥100 × 10⁹\u002FL\n  * Hemoglobin ≥8 g\u002FdL\n  * AST\u002FALT ≤2.5 × ULN\n  * Total bilirubin ≤1.5 × ULN\n  * Creatinine clearance ≥30 mL\u002Fmin\n  * Albumin ≥3 g\u002FdL\n  * PT\u002FPTT ≤1.5 × ULN\n* Willing and able to provide written informed consent\n* Negative pregnancy test for women of childbearing potential\n* Agreement to use effective contraception during study participation\n\nExclusion Criteria:\n\n* Tumor is dMMR\u002FMSI-high\n* Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents\n* Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)\n* Refractory ascites requiring frequent paracentesis or recent escalation of diuretics\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc \\>480 ms\n* Active or untreated brain metastases or leptomeningeal disease\n* Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)\n* Receipt of prior anti-cancer therapy within protocol-defined washout periods, including:\n\n  * Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.\n  * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.\n  * Small molecules\u002Ftyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.\n* Known hypersensitivity to study drugs or excipients\n* History of or active interstitial lung disease or pneumonitis requiring systemic steroids\n* Prior allogeneic transplant (organ, stem cell, or bone marrow)\n* Active or recent autoimmune disease requiring systemic treatment\n* Requirement for systemic corticosteroids (\\>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows\n* Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy\n* Recent SARS-CoV-2 infection within protocol-defined timeframe\n* Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g\u002Fg), or other clinically significant uncontrolled medical conditions\n* Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction\n* Psychiatric or substance use disorders that may interfere with study participation\n* Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study\n* Pregnant or breastfeeding women, or those planning pregnancy during the study",{"count":231,"type":22},17,[25],"The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.\n\nThe main questions it aims to answer are:\n\n* What proportion of participants experience tumor shrinkage (objective response rate) based on imaging assessments?\n* What side effects occur with this combination treatment, including immune-related and cytokine-related reactions?\n\nAll participants in this study will receive the combination treatment. There is no comparison group.\n\nParticipants will:\n\n* Receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles\n* Undergo imaging scans (such as CT or MRI) to assess tumor response\n* Have blood samples collected to monitor safety and evaluate biomarkers\n* Provide tumor tissue samples for research\n* Be monitored for side effects throughout the study\n* Participate in follow-up visits to assess survival after treatment completion",[30],[236,237,102,135,238,239,240,241,134,133,242,243],"Metastatic Colorectal Cancer","pMMR Colorectal Cancer","Checkpoint Inhibitor","Anti-PD-1","Anti-CTLA-4","iNKT Cell Therapy","agenT-797","MSS Colorectal Cancer","2026-04-21",{"date":246,"type":35},"2026-04-24",{"date":248,"type":22},"2026-06",{"date":250,"type":22},"2028-12",{"name":252,"class":42},"Darren Sigal, MD",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":65},"100564876","phase-2-isunakinra-alone-and-in-combination-with-pembrolizumab-in-patients-with-colorectal-cancer-mss-100564876","NCT06634875","Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)","A Phase IIa, Non-Randomized, Open-Label Dose Expansion Trial of Isunakinra in Combination With Pembrolizumab in Patients With Metastatic or Unresectable, Locally Advanced Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Subjects must have:\n\n  * Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum\n\n    * Tumor is determined to be RAS-mutated (KRAS, NRAS or HRAS) and microsatellite stable\u002Fproficient in mismatch repair, as assessed by immunohistochemistry (IHC) and\u002For polymerase chain reaction (PCR)\u002Fnext generation sequencing (NGS) in a Clinical Laboratory Improvement Act (CLIA) environment and with a tumor mutational burden (TMB) of 10 MB or more.\n\n      2\\. The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).\n\n      3\\. Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely to convey clinical benefit, or not be candidates for therapy of proven efficacy for their disease.\n\n      4\\. There should be a minimum of 4 weeks from any prior chemotherapy (except for the nitrosoureas and mitomycin C, requiring a minimum of 6 weeks), immunotherapy and\u002For radiation. Patients with prostate cancer on hormone deprivation therapy may continue that therapy while on study.\n\n      5\\. Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is not clinically significant).\n\n      6\\. ECOG performance status ≤ 1 7. Patients must have normal organ and hematologic function as defined below:\n    * Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL\u002Fmin.\n    * ALT and AST ≤ 3x the upper limits of normal.\n    * Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.\n    * Hematological eligibility parameters (within 16 days of starting therapy):\n\n      * Granulocyte count ≥ 1,500\u002Fmm3\n      * Platelet count ≥ 75.000\u002Fmm3 8. Patients must have baseline pulse oximetry \\> 90% on room air at rest.\n\nExclusion Criteria:\n\n1. Subjects must have:\n\n   ⦁ Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum\n\n   • Tumor is determined to be RAS-mutated (KRAS, NRAS or HRAS) and microsatellite stable\u002Fproficient in mismatch repair, as assessed by immunohistochemistry (IHC) and\u002For polymerase chain reaction (PCR)\u002Fnext generation sequencing (NGS) in a Clinical Laboratory Improvement Act (CLIA) environment and with a tumor mutational burden (TMB) of 10 MB or more.\n2. The study patients are required to have measurable disease by radiographic criteria (RECIST 1.1 and iRECIST).\n3. Prior therapy: Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease (with or without PD-1 inhibitors), with no available therapy likely to convey clinical benefit, or not be candidates for therapy of proven efficacy for their disease.\n4. There should be a minimum of 2 weeks wash out period from chemotherapy and\u002For radiation therapy, and 4 weeks wash out period for immunotherapy.\n5. Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy (for example, alopecia is not clinically significant).\n6. ECOG performance status ≤ 1\n7. Patients must have normal organ and hematologic function as defined below:\n\n   * Serum creatinine ≤ 1.5 x upper limit of normal OR creatinine clearance and a 24-h urine collection of ≥ 60 mL\u002Fmin.\n   * ALT and AST ≤ 3x the upper limits of normal.\n   * Total bilirubin ≤ 1.5 x upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin ≤ 3.0.\n   * Hematological eligibility parameters (within 16 days of starting therapy):\n\n     * Granulocyte count ≥ 1,500\u002Fmm3\n     * Platelet count ≥ 75.000\u002Fmm3\n8. Patients must have baseline pulse oximetry \\> 90% on room air at rest.\n\nExclusion criteria\n\n1. Pregnant women or women presently breast-feeding their children are excluded due to unknown risks to a developing fetus or infant, confirmed by negative pre-treatment serum pregnancy test.\n2. Concurrent treatment for cancer, with specific exceptions noted in inclusion criteria.\n3. Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.\n4. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n5. Active autoimmune diseases requiring treatment. However, patients with vitiligo, alopecia, or clinically stable autoimmune endocrine disease who are on stable dosing of appropriate replacement therapy (if such therapy is indicated) are eligible.\n6. Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited pharmacologic doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent iv contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.\n7. Patients who are receiving any other investigational agents within 28 days before start of study treatment.\n8. Patients with untreated central nervous system metastases or local treatment of brain metastases within the last 2 months. Patients with stable brain metastasis for 2 months post-intervention are eligible.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab or any of its excipients or a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.\n10. Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.\n11. HIV-positive patients are ineligible because of the potential for decreased immune response.\n12. Patients unwilling to use adequate contraception (defined as hormonal or barrier method or abstinence) prior to study entry are excluded. If the patient needs to be on adequate contraception, contraception must start before study entry and continue for 3 months after completion of study therapy.",{"count":261,"type":22},20,[25],"This study will enroll patients with colorectal cancer that is locally advanced or metastatic. The tumor must be microsatellite stable (MSS), have a tumor mutational burden that is high (TMB-H) and be kras mutated. Patients must have been treated with available approved treatments already. In this study the investigators are testing a new type of immunotherapy, the potent IL-1 inhibitor isunakinra to be added to already approved immunotherapy (PD-1\u002FPD-L1 inhibitor) in an attempt to get this treatment to work in this treatment resistant type of tumor.",[30],[266,267,268,269,270,188],"colorectal cancer","microsatellite stable","MSS","kras mutated","TMB-H","2026-03-26",{"date":273,"type":35},"2026-03-31",{"date":275,"type":35},"2025-01-30",{"date":277,"type":22},"2026-12",{"name":279,"class":89},"Buzzard Pharmaceuticals",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100630347","early-phase-1-using-healthy-gut-bacteria-to-boost-immune-treatment-for-advanced-bowel-cancer-100630347","NCT07486492","Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer","An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of MSS mCRC\n* Experienced disease progression after first-line chemotherapy and targeted therapy\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* History of FMT\n* Severe organ dysfunction (heart, lung, liver, kidney)\n* Other malignancies, psychiatric disorders, pregnancy or lactation\n* Unable to provide informed consent","75 Years",{"count":51,"type":22},[53],"This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.",[30,292],"Fecal Microbiota Transplantation","2026-03-17",{"date":295,"type":35},"2026-03-20",{"date":273,"type":22},{"date":298,"type":22},"2028-01-31",{"name":300,"class":42},"The First Affiliated Hospital of Xiamen University",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":43},"100606186","early-phase-1-infinitive-immunotherapy-for-patients-with-colorectal-liver-metastases-100606186","NCT07172282","INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases","Inclusion Criteria:\n\n* 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. A signed informed consent must be obtained prior to conducting any study-specific procedures.\n* Male or female adults 18 years of age or older on day of signing informed consent.\n* Radiographically confirmed metastatic adenocarcinoma to the liver from a colon or rectum primary tumor that is amenable to resection. TXNXM1+\n* Only participants with liver-limited, resectable metastatic disease are eligible for participation (ablations are allowed to achieve an R0 intention-to-treat outcome).\n* Only participants with pMMR (mismatch repair-proficient)\u002FMSS mCRC are eligible. Microsatellite status should be performed according to the local standard of practice. (e.g., immunohistochemistry \\[IHC\\] and\u002For polymerase chain reaction \\[PCR\\], next-generation sequencing). Subjects with unknown or indeterminant results for either test at the time of enrollment are not eligible at investigators discretion.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Patients with synchronous disease who are planned to undergo liver and resection of primary are allowed.\n* Total neoadjuvant therapy (TNT) for rectal cancers allowed.\n* In the event the patient has had prior oxaliplatin-based adjuvant chemotherapy after resection of primary tumor, a minimum interval of 6 months should have passed prior to enrollment into the study.\n* Patients must have completed standard of care FOLFOX\u002F FOLFIRI\u002FFOLFIRINOX as part of pre- operative systemic therapy.\n* Meets resectability criteria (all criteria MUST be met):\n\n  1. Tumors that can be resected completely (R0), while leaving an adequate future liver remnant (defined under c.)\n  2. The ability to preserve two contiguous hepatic segments with preservation of adequate vascular inflow and outflow as well as biliary drainage\n  3. The ability to preserve adequate future liver remnant (\\>20 percent in a healthy liver; \\>30 percent after chemotherapy)\n* Hematologic parameters defined as:\n\n  1. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3\n  2. Platelet count ≥ 100,000\u002Fmm3\n  3. Hemoglobin ≥ 8 g\u002FdL\n* Blood chemistry levels defined as:\n\n  1. AST, ALT, alkaline phosphatase ≤5 times upper limit of normal (ULN)\n  2. Total bilirubin ≤2x the ULN. Patients with Gilbert Syndrome should have a serum bilirubin ≤ 4x ULN and a direct bilirubin ≤2x ULN to be eligible.\n* Adequate renal function as estimated by glomerular filtration rate (eGFR) \\>30 L\u002Fmin determined based on the Cockcroft-Gault formula.\n* Anticipated life expectancy greater than 6 months.\n* Women of childbearing potential (WOCB) receiving systemic therapy should use effective contraception during treatment and for at least 9 months after the last investigational agent. Patients with partners who could become pregnant should use effective contraception during treatment and for 6 months after the last dose of investigational agent.\n\nExclusion Criteria:\n\n* • Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment.\n\n  * Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used as antineoplastic therapy for metastatic CRC.\n  * Receipt of any organ transplantation, including allogeneic stem cell transplantation.\n  * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, such as rheumatoid arthritis, which in the opinion of the Investigator might impair the subject's tolerance or ability to participate in the trial.\n  * Known severe hypersensitivity reactions to monoclonal antibodies.\n  * Failure to recover from any other toxicity (other than neuropathy or immune-related toxicity) related to previous anticancer treatment to grade ≤2.\n  * Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final (end of treatment) visit.\n  * Participants unable to undergo endovascular placement of TriNav PEDD catheter due to any reason.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication).\n  * Congestive heart failure ≥ New York Heart Association (NYHA) class 2.\n  * Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before start of study drug.\n  * Uncontrolled cardiac arrhythmias.\n  * Poorly controlled hypertension, defined as blood pressure consistently above 150\u002F90 mmHg despite optimal medical management.\n  * Major surgical procedure or significant traumatic injury within 28 days before start of study medication. Note: If participants received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n  * Non-healing wound, non-healing ulcer, or non-healing bone fracture.\n  * Participants with evidence or history of any bleeding diathesis, irrespective of severity.\n  * Any hemorrhage or bleeding event NCI CTCAE Grade ≥ 3 within 28 days prior to the start of study medication.\n  * Significant acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or NCI CTCAE grade ≥ 2 diarrhea of any etiology.\n  * Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus (T1DM), hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n  * Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n  * History of (non-infectious) pneumonitis that required steroids, current pneumonitis or interstitial lung disease.\n  * Ongoing infection NCI-CTCAE grade \\>2 requiring systemic therapy.\n  * Known history of positive test for HIV or known AIDS.\n  * Any known positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).\n  * Pregnant or lactating women.\n  * Previous treatment with live vaccine within 30 days of planned start of study drugs (seasonal flu vaccines that do not contain a live virus are permitted).\n  * Known history of allergy or hypersensitivity to study drug components.\n  * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the participation for the full duration of the trial.\n  * Any condition that would prohibit the understanding or rendering of informed consent.\n  * Any medical condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial.",{"count":51,"type":22},[53],"Nelitolimod is a classC toll-like receptor 9 (TLR9) agonist that binds to TLR9 receptors on myeloid-derived suppressor cells(MDSCs) and helps reshape the tumor microenvironment (TME) and promote antitumor immunity. Investigators hypothesize that Nelitolimod can induce antitumor immune response in CRLM when administered regionally to the liver via a TriNav Pressure Enabled Drug Delivery (PEDD) catheter without compromising surgical feasibility or patient safety.\n\nThe study objective is to investigate the feasibility and safety of an innovative immunotherapeutic approach for patients with CRLM designed to overcome the immunosuppressive TME in CRLM. Investigators hypothesize that this investigational neoadjuvant treatment will be well tolerated and will not prevent patients from undergoing successful, safe CRLM liver resections. Investigators will assess the safety and feasibility of Nelitolimod given via TriNav PEDD in 10 patients with CRLM prior to liver resection. Patients will receive standard treatment with chemotherapy and then undergo placement of the PEDD catheter. Patients will then receive 3 doses of Nelitolimod before undergoing liver resection.",[30],"2026-03-16",{"date":313,"type":35},"2026-03-19",{"date":315,"type":35},"2025-11-17",{"date":86,"type":22},{"name":64,"class":42},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":43},"100628516","phase-1-dual-target-car-nk-cells-for-biomarker-selected-advanced-colorectal-cancer-100628516","NCT07462650","Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer","A Phase 1\u002F2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and\u002For GUCY2C (GCC) With an Exploratory HER2\u002FERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.\n* Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).\n* Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.\n* Recovered to Grade \\\u003C=1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).\n* Life expectancy \\>= 12 weeks.\n* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled HBV\u002FHCV) or known uncontrolled HIV infection.\n* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)\n* Prior gene-modified cellular therapy (CAR-T\u002FCAR-NK\u002FTCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.\n* Pregnant or breastfeeding.\n* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.\n* Known hypersensitivity to study chemotherapy components (fludarabine\u002Fcyclophosphamide) or required supportive medications.\n* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.",{"count":326,"type":22},48,[76,25],"This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy\u002Fbiomarker signals) will be selected for dose expansion.",[30,330],"Adenocarcinoma of Colon",[332,333,334,335,336,337,214,338,339,340,341],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","2026-03-08",{"date":344,"type":35},"2026-03-10",{"date":346,"type":35},"2026-02-01",{"date":348,"type":22},"2028-12-22",{"name":350,"class":89},"Beijing Biotech",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":367,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100624138","phase-2-lubiprostone-combined-with-maintenance-therapy-for-prevention-of-postoperative-recurrence-in-peritoneal-metastatic-colorectal-cancer-100624138","NCT07405736","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study","Inclusion Criteria:\n\n* Voluntarily participates and provides written informed consent.\n* Histologically confirmed colon\u002Frectal adenocarcinoma with molecular status confirmed as pMMR or MSS.\n* Cytoreductive surgery (CRS) achieves CC0\u002FCC1 cytoreduction.\n* No extraperitoneal metastasis prior to treatment.\n* ECOG performance status 0-1 with adequate organ function per protocol requirements.\n\nExclusion Criteria:\n\n* Extensive multisystem metastases on baseline imaging assessment.\n* Tumor carrying BRAF V600E mutation.\n* dMMR\u002FMSI-H, or confirmed pathogenic POLE\u002FPOLD1 mutation(s).\n* Cachexia or decompensated organ dysfunction.\n* History of another malignancy within the past 5 years.\n* Known or suspected hypersensitivity\u002Fallergy to the study drug or related formulations.\n* Multiple primary cancers.\n* Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.",{"count":359,"type":22},124,[25],"The goal of this phase II randomized controlled clinical trial is to evaluate whether adding lubiprostone to standard postoperative maintenance therapy can delay disease progression and recurrence in adult patients with colorectal cancer and peritoneal metastases (PM-CRC) who have undergone cytoreductive surgery with or without HIPEC after systemic treatment. The main questions it aims to answer are:\n\nDoes lubiprostone plus maintenance therapy improve the 1-year progression-free survival (PFS) rate compared with maintenance therapy alone?\n\nIs lubiprostone safe and feasible for long-term use during the maintenance period in this PM-CRC population?\n\nResearchers will compare lubiprostone + maintenance therapy versus maintenance therapy alone to see if the addition of lubiprostone prolongs PFS, reduces the risk of distant metastasis, improves overall survival, and maintains or improves quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive maintenance therapy with lubiprostone or maintenance therapy alone after surgery (CRS ± HIPEC) and prior systemic therapy, according to the study protocol.\n\nUndergo scheduled follow-up assessments for disease status (progression\u002Frecurrence), survival outcomes, treatment-related toxicity, and quality of life using the EORTC QLQ-C30 (v3.0) questionnaire.",[30,363,364,365,366],"Peritoneal (Metastatic) Cancer","Peritoneal Metastasis","Colorectal Cancer (CRC)","MSS Metastatic Colorectal Cancer",[368,369,370,371,372,373],"Peritoneal metastasis","Colorectal cancer","Maintenance therapy","Lubiprostone","Cytoreductive Surgery","Progression-free survival","2026-02-10",{"date":376,"type":35},"2026-02-12",{"date":378,"type":22},"2026-02-24",{"date":380,"type":22},"2028-06-01",{"name":382,"class":42},"Sun Yat-sen University",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":98,"studyType":99,"phases":4,"briefSummary":392,"conditions":393,"keywords":396,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":43},"100569738","colorectal-metastasis-to-liver-extraction-with-auxiliary-transplant-and-delayed-resection-100569738","NCT06698146","Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection","Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study","CLEAR","Inclusion:\n\n1. All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).\n2. Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.\n\nExclusion:\n\n1. Adults unable to consent\n2. Pregnant Women\n3. Certain clinical\u002Fsurgical\u002Fanatomical parameters, at the discretion of the PI.",{"count":206,"type":22},"Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).",[394,30,395],"Liver Transplant Surgery","Colon Cancer Liver Metastases",[397,30,131],"Liver Transplant","2026-02-06",{"date":374,"type":35},{"date":401,"type":35},"2025-08-27",{"date":403,"type":22},"2035-01-01",{"name":405,"class":42},"Northwestern University",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":43},"100608435","phase-2-study-of-safetyfeasibility-of-a-hybrid-model-of-tertiary-and-community-delivery-of-hepatic-artery-infusion-chemotherapy-100608435","NCT07201519","Study of Safety\u002FFeasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","Phase IIa Study of Safety\u002FFeasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","Inclusion Criteria:\n\n* Colorectal adenocarcinoma metastatic to the liver which is either Unresectable (group A) or Resectable (group B; ie, will be completely resected), AND with no definitive clinical or radiographic evidence of extrahepatic disease other than: metastatic disease to resectable peri-hepatic lymph nodes; up to 5 proven or suspected lung metastases, provided they are stable or responding in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to SBRT or resection. or\n* Histologically confirmed unresectable intrahepatic cholangiocarcinoma (group C), with presence of less than 70% liver involvement with no definitive clinical or radiographic evidence of extrahepatic metastatic disease other than resectable perihepatic lymph nodes.\n* Patients \\> or equal 18 years of age\n* ECOG Performance Status of 0 - 1 (APPENDIX C)\n* Lab Values \\\u003C or equal 14 days prior to study enrollment: absolute neutrophil count \\> or equal 1,500\u002FmcL Total Bilirubin \\\u003C or equal 1.5 mg\u002FdL AST\u002FALT \\\u003C 5 x institutional upper limit of normal (ULN) Platelets \\> or equal 100,000\u002FmcL Creatinine \\\u003C 1.5 mg\u002FdL HGB \\> 8 g\u002FdL INR \\\u003C or equal 1.5\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Prior chemotherapy is acceptable if last dose given \\> or equal 3 weeks prior to study enrollment\n* Any investigational agent is acceptable if last dose administered \\> or equal 3 months before study enrollment\n* In order for patients to select treatment in the CO arm, they must have the ability to do telehealth visits, either via a home computer, tablet, or smartphone, either via home internet access or cellphone network.\n\nExclusion Criteria:\n\n* Presence of distant non-liver metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. For the colorectal carcinoma only: Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for minimum of 2-mos of systemic chemo and are amenable to SBRT.\n* Microsatellite instability (MSI) or Mismatch repair deficiency (MMR-D)\n* Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable\n* Bevacizumab (Avastin®) cannot be given concurrently with HAI FUDR. Patients can previously have received it with a minimum 6-week washout period\n* Active infection, hepatic encephalopathy\n* Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis) are exclusions. Note: surgically-related ascites does not exclude the patient.\n* Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of childbearing potential must have negative pregnancy test prior to surgery)\n* If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment\n* Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy; Patients with a history of stroke within 3 months or with substantial residual deficit, based on investigator discretion\n* Serious or non-healing active wound, ulcer, or bone fracture\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)\n* Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples: active substance abuse, active severe alcohol abuse, etc.\n* Inability to reliably commit to traveling to either Lexington, KY (for patients choosing TO site for HAI administration) or local CO site every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.\n* Patients with AXIOS™ stents (or similar) used to connect the small intestine to the gastric remnant after a prior gastric bypass for access for ERCP\u002Fstent in the setting of biliary obstruction are eligible at the discretion of the investigator. Considerations regarding eligibility comprise removal of the stent prior to HAIP implantation, or the placement of the HAIP catheter at least 5cm away from the AXIOS stent.","99 Years",{"count":206,"type":22},[25],"The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are:\n\n* safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver)\n* help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital\n\nParticipants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center.\n\nThe main treatment on study will last about 3-4 months.",[30,418],"Intrahepatic Cholangiocarcinoma",[420,421,422],"hepatic artery infusion","chemotherapy","floxuridine",{"date":424,"type":35},"2026-02-04",{"date":426,"type":35},"2026-01-23",{"date":428,"type":22},"2030-02",{"name":430,"class":42},"Michael J Cavnar, MD",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":452,"locationsCount":43},"100497629","phase-1-a-study-of-cna3103-lgr5-targeted-autologous-car-t-cells-administered-to-subjects-with-metastatic-colorectal-cancer-100497629","NCT05759728","A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer","A Phase 1\u002F2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Signed written Informed Consent.\n* Male and female subjects aged greater than or equal to18 years.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 to 1.\n* Histologically or cytologically confirmed metastatic colorectal cancer previously treated with no more than 2 prior fluoropyrimidine, oxaliplatin, and\u002For irinotecan-based regimens for metastatic disease. Antibody-drug conjugates (ADCs) administered in the metastatic setting are also considered cytotoxic treatment and would count as a prior regimen. Neoadjuvant\u002Fadjuvant treatment of resectable oligometastatic disease, does not count as a prior line of therapy in the palliative setting unless there is development of an unresectable local or distant recurrence within 6 months of its last dose.\n\nSubjects who discontinue their prior regimen due to toxicity (in the absence of disease recurrence\u002Fprogression) will also have their prior therapy count as one prior regimen. Anti-Kirsten rat sarcoma virus (Anti-KRAS) agents are also allowable. The planned lymphodepletion start date must be at least 4 weeks from last chemotherapy, biologic, radiotherapy, or investigational therapy (excluding bridging therapy), with resolution of all lingering toxicities to Grade ≤ 1, with the exception of neuropathy and alopecia.\n\nSubjects previously treated in the adjuvant\u002Fneoadjuvant setting with an oxaliplatin\u002Firinotecan regimen, who develop an unresectable local recurrence and\u002For metastatic disease within 6 months of the date of last oxaliplatin\u002Firinotecan chemotherapy will have their adjuvant\u002F neoadjuvant therapy count as one prior regimen.\n\n* Positive for any level of LGR5 expression in tumor biopsies.\n* Measurable or evaluable disease per RECIST version 1.1. Subjects with lung metastases involving less than or equal to 20% of both lung fields and with good respiratory reserves would be deemed eligible as long as the lesions do not compromise airways, vascular, pleural, or mediastinal spaces. Both measurable and non-measurable (evaluable) lesions would count for this assessment.\n\nSubjects whose lung metastases involve more than 20% of both lung fields should be discussed with the Sponsor in more detail, taking into account disease tempo, clinical symptoms, respiratory function and compromise (current or impending) of airways, vascular, pleural, or mediastinal spaces. Both measurable and non-measurable (evaluable) lesions would count for this assessment.\n\n* Life expectancy of at least \\>12 weeks.\n* Normal organ and marrow function.\n* No clinically significant abnormalities in urinalysis results at Screening.\n* No known clinically significant gastrointestinal disease within 28 days prior to enrolment.\n* No ongoing requirement for anti-diarrheal therapy.\n* For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement (by subject and\u002For partner) to use a highly effective form of contraception and to continue its use for 6 months after the last dose of IP.\n* Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to CNA3103 administration.\n\nExclusion Criteria:\n\n* Inability to comply with study and follow-up procedures.\n* Women who are pregnant or lactating.\n* Has BRAF-mutated colorectal cancer.\n* Has received trifluridine\u002Ftipiracil (TAS-102) or regorafenib for metastatic disease.\n* Treatment with chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiation therapy as cancer therapy (excluding bridging therapy) within 4 weeks prior to the lymphodepletion start date.\n* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent in the previous 28 days prior to enrolment.\n* Have received antibody-based therapies within the previous 28 days or 5 half-lives of the agent, whichever is shorter.\n* Major surgery, in the previous 4 weeks prior to enrolment.\n* Clinically detectable pleural effusion requiring drainage in the 4 weeks prior to enrolment.\n* Any uncontrolled medical or psychiatric risk factors which would contraindicate the use or impair the ability of the subject to provide informed consent, receive protocol therapy or may impose excessive risk to the subject.\n* Known central nervous system (CNS) disease.\n* Current use of medications that may have the potential of QTc prolongation.\n* Uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.\n* Has a known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, alcoholic or other hepatitis, or cirrhosis.\n* Inability to be venipunctured and\u002For tolerate venous access.\n* Second malignancies within 5 years prior to enrollment, except for those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent.\n* Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of ≤10 mg\u002Fday prednisone.\n* History of inflammatory bowel disease (active or past) or active peptic ulcer disease.\n* History of connective tissue disorders.\n* History of chronic leukemias.\n* History of previous, whole abdomen radiation therapy (or total pelvic radiation therapy) or more than Grade 1 residual toxicity from previous radiation therapy.\n* High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year\n* Left ventricular ejection fraction \\\u003C50%.\n* Have had a venous thromboembolic event requiring anticoagulation.\n* Congenital or acquired long QT syndrome.\n* QTc prolongation.\n* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.\n* Patients with ascites, previous drainage of ascites, peritoneal caking, and\u002For significant peritoneal deposits at Baseline are excluded from participation in the study\n* Patients with reduced liver reserves and\u002For possibility of hepatobiliary complications, including, but not limited to; portal hypertension, liver resection (segmentectomy, metastasectomy) in the previous 6 months, patients with existing biliary stents or the need to receive a biliary stent to relieve bile duct obstruction of any etiology, patients with cholelithiasis, patients who abuse alcohol or paracetamol (with or without concomitant alcohol abuse), patients who use herbal medicines, and patients with substance abuse.",{"count":439,"type":22},45,[76,25],"This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 \\[LGR5\\]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer.\n\nParticipants may undergo a pre-screening biopsy procedure to determine expression of LGR5.\n\nParticipants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing.\n\nParticipants will receive a single Intravenous dose of CNA3103.\n\nExpansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage.\n\nParticipants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event\u002Fs, death or withdrawal of consent.",[30],[444,445],"CAR-T","LGR5","2026-01-11",{"date":448,"type":35},"2026-01-13",{"date":450,"type":35},"2023-10-24",{"date":142,"type":22},{"name":453,"class":89},"Carina Biotech Limited",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":43},"100618166","early-phase-1-colonyvaq-a-quantum-classical-guided-personalized-neoantigen-vaccine-for-mss-stage-iii-colorectal-cancer-100618166","NCT07328087","COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer","COLONYVAQ™-CRC, a Physics-aware, Quantum-Classical AI-Guided Personalized Neoantigen Peptide Vaccine, Administered in Combination With Standard Adjuvant Oxaliplatin-based Chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab 3 mg\u002Fkg in Patients With Completely Resected Stage III Microsatellite-stable (MSS)","COLONYVAQ™-CRC","* Eligibility\n* Inclusion Criteria\n\n  * \\*\\*Diagnosis \u002F Histology\\*\\*\n  * Histologically confirmed adenocarcinoma of the colon or rectum.\n  * Pathology report available for central or sponsor review (if requested), including:\n  * Primary tumor site (colon vs rectum)\n  * Grade of differentiation\n  * Resection margins\n  * \\*\\*Stage and Surgical Status\\*\\*\n  * Pathologic stage III disease (any T, N1-2, M0) per AJCC 8th edition.\n  * R0 resection of the primary tumor documented by operative and pathology reports (no macroscopic or microscopic residual tumor at margins).\n  * No evidence of distant metastatic disease (M1) on staging imaging (CT chest\u002Fabdomen\u002Fpelvis ± MRI\u002FPET per institutional standard) within a protocol-defined window (e.g., ≤8 weeks prior to enrollment).\n  * Enrollment and treatment initiation planned within a protocol-defined timeframe after surgery (e.g., 4-12 weeks post-resection), allowing appropriate recovery.\n  * \\*\\*Molecular Subtype (MSS\u002FpMMR)\\*\\*\n  * Tumor confirmed MSS or pMMR by local testing using one or more of the following:\n  * IHC for MLH1, MSH2, MSH6, and PMS2\n  * PCR-based MSI panel\n  * NGS-based MSI\u002FMMR assessment\n  * No evidence of dMMR\u002FMSI-H status or POLE ultramutated phenotype.\n  * \\*\\*High-Risk Recurrence Profile\\*\\*\n  * At least one protocol-defined high-risk feature, including one or more of the following:\n  * Pathologic T4 tumor\n  * Pathologic N2 nodal status (≥4 positive lymph nodes)\n  * Positive postoperative ctDNA (MRD) by a validated tumor-informed assay within a protocol-defined window after surgery\u002Fchemotherapy initiation\n  * Other protocol-specified high-risk features (e.g., lymphovascular invasion, perineural invasion, poorly differentiated histology, inadequate lymph node sampling), as defined in the protocol\u002Fstatistical analysis plan\n  * \\*\\*Suitability for Standard Adjuvant Chemotherapy\\*\\*\n  * Candidate for oxaliplatin-based adjuvant chemotherapy with one of the following:\n  * mFOLFOX6 every 14 days for \\~6 months, \\*\\*or\\*\\*\n  * CAPOX (XELOX) every 21 days for \\~3-6 months\n  * Chemotherapy regimen (mFOLFOX6 vs CAPOX) determined before enrollment and recorded as a stratification factor.\n  * No contraindications to oxaliplatin, 5-fluorouracil, leucovorin, or capecitabine (e.g., severe DPD deficiency; prior severe 5-FU\u002Fcapecitabine toxicity).\n  * \\*\\*Suitability for Nivolumab\\*\\*\n  * Eligible in the investigator's judgment to receive anti-PD-1 therapy (nivolumab 3 mg\u002Fkg IV every 2 weeks), including:\n  * No history of severe (Grade ≥3) immune-related adverse events from prior immunotherapy\n  * No active autoimmune disease requiring systemic immunosuppression\n  * \\*\\*Performance Status\\*\\*\n  * ECOG performance status 0-1 at screening.\n  * \\*\\*Adequate Organ and Marrow Function\\*\\* (documented within 14 days prior to enrollment; no transfusions\u002Fgrowth factors solely to meet eligibility)\n  * \\*\\*Hematologic\\*\\*\n  * ANC ≥ 1.5 × 10⁹\u002FL\n  * Platelets ≥ 100 × 10⁹\u002FL\n  * Hemoglobin ≥ 9.0 g\u002FdL (transfusions allowed if clinically indicated, but not solely to qualify)\n  * \\*\\*Hepatic\\*\\*\n  * Total bilirubin ≤ 1.5 × ULN (≤3 × ULN allowed for known Gilbert's syndrome if direct bilirubin is normal)\n  * AST and ALT ≤ 2.5 × ULN\n  * Alkaline phosphatase ≤ 2.5 × ULN (higher thresholds may be allowed for non-malignant causes per protocol)\n  * \\*\\*Renal\\*\\*\n  * Serum creatinine ≤ 1.5 × ULN \\*\\*or\\*\\* creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault or institutional standard)\n  * \\*\\*Biospecimen Availability (COLONYVAQ)\\*\\*\n  * Adequate tumor tissue available from resected primary tumor (and\u002For metastases if applicable), including one of the following:\n  * Fresh frozen tissue (preferred), \\*\\*or\\*\\*\n  * FFPE block(s), \\*\\*or\\*\\*\n  * ≥15 unstained slides (or equivalent) suitable for DNA\u002FRNA extraction\n  * Matched normal sample (peripheral blood) available for germline DNA sequencing.\n  * Willingness to provide additional blood samples for ctDNA, immune monitoring, and exploratory assays per schedule.\n  * Pre-existing WES\u002FRNA-seq may be accepted if meeting COLONYVAQ requirements per protocol.\n  * \\*\\*Neoantigen Suitability\\*\\*\n  * At least one predicted high-quality tumor neoantigen identified by the COLONYVAQ pipeline meeting prespecified criteria, including:\n  * Strong predicted binding to patient-specific HLA alleles (e.g., Kd in an established binder range)\n  * Evidence of tumor RNA expression of the source gene\u002Fallele\n  * Prioritization by multi-algorithm immunogenicity scoring and passage through COLONYVAQ quantum-geometric, thermodynamic, and immunogenicity gates\n  * \\*\\*OR\\*\\*\n  * Availability of pre-manufactured GMP-grade neoantigen peptides with demonstrated in vitro immunogenicity and acceptable safety profile.\n  * \\*\\*Life Expectancy\\*\\*\n  * Investigator-estimated life expectancy ≥ 3 years in the absence of CRC recurrence.\n  * \\*\\*Contraception and Pregnancy\\*\\*\n  * \\*\\*Women of childbearing potential (WOCBP)\\*\\*\n  * Negative serum or urine pregnancy test within 7 days prior to randomization\n  * Agreement to use highly effective contraception during treatment and for a protocol-defined period after last dose (e.g., 5 months after last nivolumab and 6 months after last chemotherapy, or per label\u002Finstitutional guidance)\n  * \\*\\*Men with partners of childbearing potential\\*\\*\n  * Agreement to use effective contraception and avoid sperm donation during treatment and for the protocol-defined period after last dose\n  * \\*\\*Informed Consent and Compliance\\*\\*\n  * Able to understand and voluntarily sign written informed consent.\n  * Willing and able to comply with all study procedures (visits, imaging, blood draws, follow-up).\n* Exclusion Criteria\n\n  * \\*\\*Residual or Metastatic Disease at Baseline\\*\\*\n  * R2 resection or indeterminate margins not clearly R0.\n  * Radiologic or histologic evidence of distant metastases (M1) at baseline staging (e.g., liver, lung, peritoneum).\n  * Gross residual disease at the primary site.\n  * \\*\\*Mismatch Repair-Deficient \u002F MSI-High \u002F POLE-Ultramutated Disease\\*\\*\n  * Known dMMR\u002FMSI-H CRC or POLE ultramutated tumors for which checkpoint inhibition is standard\u002Fpreferred.\n  * \\*\\*Prior Anticancer Therapy (Beyond Allowed Neoadjuvant)\\*\\*\n  * Prior systemic therapy for metastatic CRC.\n  * Neoadjuvant chemotherapy\u002Fchemoradiotherapy that:\n  * Was not completed within protocol-defined windows, \\*\\*or\\*\\*\n  * Led to unresolved Grade ≥2 non-hematologic toxicity (excluding alopecia or clinically insignificant neuropathy, per protocol)\n  * Prior tumor vaccine targeting TAAs or neoantigens (peptide, DC, viral, RNA, or DNA).\n  * Prior immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-CTLA-4).\n  * \\*\\*Active or Uncontrolled Infections\\*\\*\n  * Systemic infection requiring IV or oral antimicrobials that would interfere with study treatment per investigator judgment.\n  * Uncontrolled HIV (e.g., CD4 below protocol threshold or unsuppressed viral load).\n  * Active hepatitis B with HBV DNA above predefined limit, or active hepatitis C with detectable HCV RNA not adequately treated.\n  * Other clinically significant infections posing excessive risk with immunotherapy, vaccine, or chemotherapy.\n  * \\*\\*Autoimmune Disease \u002F Immunosuppression\\*\\*\n  * Severe\u002Funcontrolled autoimmune disease requiring systemic immunosuppression (e.g., high-dose corticosteroids, biologics), including (examples):\n  * Systemic lupus erythematosus\n  * Inflammatory bowel disease with recent flares\n  * Rheumatoid arthritis requiring biologics\n  * Multiple sclerosis\n  * Myasthenia gravis\n  * Exceptions may include (per protocol):\n  * Stable autoimmune thyroiditis on replacement therapy\n  * Vitiligo\n  * Well-controlled type 1 diabetes\n  * Chronic systemic corticosteroids \\>10 mg prednisone equivalent daily (or other immunosuppressants) within a protocol-defined window prior to first dose (unless physiologic\u002Fadrenal replacement).\n  * \\*\\*Transplant History\\*\\*\n  * Prior allogeneic hematopoietic stem cell transplantation.\n  * Prior solid organ transplantation (e.g., kidney, liver, heart).\n  * \\*\\*Hypersensitivity \u002F Drug Intolerance\\*\\*\n  * Severe hypersensitivity (e.g., anaphylaxis) to any of the following:\n  * COLONYVAQ-CRC components (peptides\u002Fexcipients)\n  * Poly I:C or similar TLR agonists\n  * Nivolumab or other anti-PD-1\u002FPD-L1 agents\n  * Oxaliplatin, 5-FU, leucovorin, or capecitabine (including severe DPD deficiency)\n  * \\*\\*Concurrent Malignancy\\*\\*\n  * Active second primary malignancy requiring systemic therapy or expected to require systemic therapy during the trial.\n  * Exceptions:\n  * Adequately treated basal cell or squamous cell skin carcinoma\n  * Cervical carcinoma in situ\n  * Other malignancies in complete remission not expected to relapse or require systemic therapy within 5 years, per investigator judgment\n  * \\*\\*Significant Comorbidities\\*\\*\n  * Clinically significant\u002Funstable cardiovascular disease, including:\n  * MI within 6 months\n  * Unstable angina\n  * Uncontrolled arrhythmias\n  * CHF NYHA class III-IV\n  * Uncontrolled hypertension despite medical therapy\n  * Stroke or TIA within 6 months (if risk is increased per investigator judgment).\n  * Severe COPD or interstitial lung disease with significant impairment, or prior pneumonitis requiring systemic steroids.\n  * Any other serious uncontrolled condition (e.g., poorly controlled diabetes, severe cirrhosis, advanced renal failure) that may compromise safety or adherence.\n  * \\*\\*Pregnancy \u002F Lactation\\*\\*\n  * Pregnant at screening (positive pregnancy test).\n  * Breastfeeding (must discontinue lactation before first dose).\n  * \\*\\*Concurrent Investigational Agents \u002F Confounding Therapies\\*\\*\n  * Participation in another interventional trial with systemic investigational agents (unless sponsor\u002FIRB-approved and not confounding).\n  * Live attenuated vaccine within a protocol-defined period (e.g., 30 days) prior to first dose of nivolumab or COLONYVAQ-CRC, or during study treatment.\n  * \\*\\*Other Conditions Affecting Compliance or Assessment\\*\\*\n  * Psychiatric illness, cognitive impairment, substance abuse, or social situation limiting adherence to study requirements.\n  * Any condition that, in the investigator's opinion, makes the participant unsuitable or interferes with interpretation of safety, immunologic, or clinical outcomes.",{"count":463,"type":22},12,[53],"This is an early phase I, single-arm, open-label clinical study designed to evaluate the safety, tolerability, and feasibility of COLONYVAQ-CRC, a physics-aware, quantum-classical AI-guided personalized neoantigen peptide vaccine, administered in combination with standard adjuvant oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX) and nivolumab 3 mg\u002Fkg in patients with completely resected stage III microsatellite-stable (MSS) \u002F proficient mismatch repair (pMMR) colorectal cancer. An initial safety cohort of 12 patients will be enrolled and closely monitored for toxicity attributable to the experimental vaccine preparation. If, among these 12 patients, fewer than 3 develop experimental-preparation-related toxicity greater than grade 2 and no patient develops experimental-preparation-related grade 4 toxicity, the study will expand to enroll a total of 50 patients. Primary objectives focus on safety and tolerability of the combination regimen. Secondary and exploratory objectives characterize neoantigen-specific immune responses, ctDNA dynamics, T-cell receptor (TCR) clonotype evolution, tumor immune microenvironment features, and preliminary disease control (disease-free survival and overall survival) to inform subsequent phase II design.",[30,467,468],"Colorectal Cancer Stage III","Colorectal Cancer Stage IV",[470,471,472],"CRC Patient-specific vaccine,","AI-Quantum guided neoantigen selection,","Machine learning-based neoantigen prediction,","2026-01-07",{"date":475,"type":35},"2026-01-09",{"date":477,"type":22},"2026-02-02",{"date":479,"type":22},"2031-12-02",{"name":481,"class":89},"Biogenea Pharmaceuticals Ltd.",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":4},"100537846","phase-1-a-clinical-study-of-biottt001-in-combination-with-toripalimab-and-regorafenib-in-patients-with-colorectal-cancer-100537846","NCT06283134","A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer","A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer","Inclusion Criteria:\n\n1. Age range from 18 to 70 years old (including the threshold), no gender restrictions;\n2. Patients with a definitive histopathological or cytological diagnosis of colorectal cancer with hepatic metastases who have received and failed at least second-line standard therapy in the past, or who have been assessed by the investigator to be unsuitable for standard therapy;\n3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n4. WBC≥3.0×10\\^9\u002FL; ANC≥1.5×10\\^9\u002FL (without cytokine therapy within one week before the screening ); Hb≥90g\u002FL(without blood transfusion within one week before the screening);PLT≥90×10\\^9\u002FL(without Platelet transfusion or thrombopoietin (TPO) within one week before the screening)；ALT and AST≤5×ULN；Cr≤1.5×ULN or CCr\\>50mL\u002Fmin; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR\u002FPT≤1.5×ULN；\n5. ECOG 0\\~2；\n6. Expected survival ≥ 3 months;\n7. Consent to contraception；\n8. Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.\n\nExclusion Criteria:\n\n1. Known allergy to the investigational drug or its components;\n2. Previous treatment with other adenovirus drugs;\n3. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia);\n4. Received treatment with nitrosourea or mitomycin C within 6 weeks before the first dose of BioTTT001; received oral fluorouracil and small molecule targeted drug therapy within 2 weeks or 5 half-lives of the drug within 2 weeks before the first dose of BioTTT001; received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks before the first dose of BioTTT001; received chemotherapy, radiotherapy, biological therapy other than the drugs mentioned above within 28 days before the first dose of BioTTT001；\n5. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).\n6. History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ, Papillary carcinoma of thyroid gland, low-risk GIST etc.) within 5 years before study drug administration;\n7. Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 4 weeks before the first dose of BioTTT001;\n8. Patients who have been treated with high-dose systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001;\n9. NYHA≥grade 3; LVEF\\\u003C50%; male QTc\\>450 mms, female QTc\\>470 mms;\n10. Patients with active tuberculosis or drug-induced interstitial lung disease；\n11. Patients with active infection requiring systemic anti-infective therapy;\n12. In a state of immunosuppression, such as severe combined immunodeficiency disease or concurrent opportunistic infections;\n13. HBsAg positive, and blood HBV DNA≥100 IU\u002FmL; anti-HCV positive; HIV positive; active syphilis;\n14. Patients with pleural effusion and ascites with clinical symptoms that require repeated drainage;\n15. Patients with central nervous system metastases or meningeal metastases with clinical symptoms;\n16. Patients with contraindications to hepatic arterial perfusion therapy;\n17. Pregnant or lactating women;\n18. Patients with prior organ transplants;\n19. Other reasons judged by the investigator.",{"count":490,"type":22},60,[76],"This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.",[30],[495,496,497,420],"oncolytic virus","colorectal Cancer","liver metastasis","2026-01-04",{"date":473,"type":35},{"date":501,"type":22},"2026-03",{"date":503,"type":22},"2028-12-01",{"name":505,"class":42},"China Medical University, China",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":43},"100609360","phase-2-stream-2-second-line-treatment-with-regorafenib-in-advanced-ras-mutant-colorectal-cancer-100609360","NCT07213570","STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer","Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Either sex aged ≥ 18.\n3. Histologically proven of colorectal adenocarcinoma.\n4. Diagnosis of metastatic disease.\n5. RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR\u002FMSI status.\n6. Achieved a PFS in first line \\> 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n8. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n9. Estimated life expectancy of more than 12 weeks\n10. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n11. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n12. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n13. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n14. Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory.\n\nExclusion Criteria:\n\n1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Any contraindication to regorafenib.\n3. Not received immunotherapy if dMMR or MSI-H.\n4. Major surgical intervention within 4 weeks prior to enrollment.\n5. Pregnancy and breast-feeding.\n6. Any brain metastasis.\n7. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n8. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n9. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n10. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.\n11. Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD)",{"count":490,"type":22},[25],"The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.",[30],[518,519,520,521],"metastatic colorectal cancer","liquid biopsy","Regorafenib","RAS-mutation","2025-12-16",{"date":524,"type":35},"2025-12-17",{"date":526,"type":35},"2025-10-16",{"date":528,"type":22},"2027-04",{"name":530,"class":42},"National Cancer Institute, Naples",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":557},"100570985","phase-2-valproic-acid-to-potentiate-anti-egfr-treatment-efficacy-and-preventrevert-resistance-in-colorectal-cancer-100570985","NCT06714357","ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent\u002FRevert Resistance in Colorectal Cancer","Randomized Phase 2 Study of Valproic Acid Combined With Rechallenge Anti-EGFR Based Regimen Regimens in Pretreated Patients With RAS\u002FBRAF Wild-type Metastatic Colorectal Cancer - VICTORIA Trial","VICTORIA","Inclusion Criteria (Study Part 1):\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Either sex aged ≥ 18.\n3. Histologically proven of colorectal adenocarcinoma.\n4. Diagnosis of metastatic disease.\n5. RAS\u002FBRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR\u002FMSI status\n6. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing).\n7. Patient candidate to anti-EGFR rechallenge therapy with panitumumab and irinotecan as clinical practice; Efficacy of anti-EGFR drug in any line of treatment with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or stable disease ≥ 6 months and received a subsequent line of therapy upon progression.\n\n   a. Note. Patients must have received at least 2 lines of treatment. Previous treatment with regorafenib, trifluridine\u002Ftipiracile, trifluridine\u002Ftipiracile + bevacizumab or fruquintinib is allowed. Previous rechallenge with anti-EGFR MoAb is NOT allowed. Adjuvant treatment will be considered as one line of therapy in case of progression within 6 months from the last dose of treatment.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n9. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n10. Estimated life expectancy of more than 12 weeks\n11. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n12. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n13. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n14. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n\nExclusion Criteria (Study Part 1):\n\n1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Any contraindication to panitumumab or irinotecan.\n3. Not received immunotherapy if dMMR or MSI-H.\n4. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.\n5. Major surgical intervention within 4 weeks prior to enrollment.\n6. Pregnancy and breast-feeding.\n7. Any brain metastasis.\n8. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc .\n9. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n10. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n11. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n12. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.\n13. History of interstitial pneumonitis or pulmonary fibrosis.\n14. History of corneal perforation or ulceration keratitis.\n15. Hypersensitivity to valproic acid or any of listed excipients.\n16. Acute hepatitis or chronic hepatitis.\n17. Personal or familial anamnesis of severe hepatopathy.\n18. History of Hepatic porphyria\n19. Known coagulation disorders.\n20. Known Polymerase-gamma (POLG) mitochondrial mutation (e.g. Alpers-Huttenlocher Syndrome).\n21. Known urea cycle disorders.\n\n    * Inclusion Criteria (Study Part 2):\n\n1\\. Have provided written informed consent to study procedures and to correlative studies.\n\n2\\. Enrolled in VICTORIA - Study Part 1 and randomized to ARM A (control arm) 3. Progressed to treatment within ARM A (control arm). 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n\n5\\. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 6. Estimated life expectancy of more than 12 weeks. 7. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL. 8. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN. 9. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula). 10. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n\n-Exclusion Criteria (Study Part 2):\n\n1. Did not receive a subsequent line of therapy upon progression to ARM A.\n2. Any brain metastasis.\n3. Pregnancy and breast-feeding.\n4. Serious Adverse events with panitumumab or irinotecan, leading to treatment interruption and discontinuation.\n5. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc\n6. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n7. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.",{"count":540,"type":22},130,[25],"The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting.\n\nCorrelative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.",[30],[545,546,547,548,549,550],"Metastatic colorectal cancer","RAS\u002FBRAF wt","Liquid biopsy","Valproic Acid","anti-EGFR treatment","epigenetic reprogramming",{"date":524,"type":35},{"date":553,"type":35},"2025-03-12",{"date":555,"type":22},"2027-06-20",{"name":530,"class":42},8,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":43},"100557608","phase-2-clinical-study-of-second-line-treatment-in-advanced-colorectal-cancer-with-chemotherapy-with-bevacizumab-or-cetuximab-100557608","NCT06540326","Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab","Clinical Study of Second-line Treatment of Patients With Advanced Colorectal Cancer With Irinotecan Liposome (II), Fluorouracil in Combination With Bevacizumab or Cetuximab","Inclusion Criteria:\n\n1. Provide written informed consent to voluntarily enroll in this study.\n2. Men or women aged 18-75 years.\n3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n4. Patients who have failed one prior systemic therapy.\n5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.\n6. Life expectancy of at least 3 months.\n7. Measurable lesions at baseline as assessed by the investigator by imaging (according to RECIST 1.1), measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred).\n8. Function of vital organs in accordance with the following requirements (no medication with any blood component, cell growth factor corrective therapy is allowed within 14 days prior to the first administration of study drug); Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL Platelets ≥ 100 x 109\u002FL; Haemoglobin ≥ 9 g\u002FdL; Serum albumin ≥ 2.5 g\u002FdL; Total bilirubin ≤ 1.5 × upper limit of normal; alanine aminotransferase, aspartate aminotransferase≤ 2.5 × upper limit of normal, and if liver metastases are present, alanine aminotransferase, aspartate aminotransferase ≤ 5 × upper limit of normal Serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault); Activated partial thromboplastin time (APTT) and International Normalised Ratio (INR) ≤ 1.5 × upper limit of normal (screened for use of stable doses of anticoagulant therapy such as low molecular heparin or warfarin where the INR is within the expected therapeutic range of the anticoagulant).\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiation of trial drug administration and use effective contraception (e.g., intrauterine device, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose of trial drug; for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for at least 3 months after the last dose of trial drug. For male subjects whose partners are women of childbearing potential\n\nExclusion Criteria:\n\n1. Have received local radiotherapy within 4 weeks prior to the first dose of study drug and have not recovered to baseline levels of adverse events due to radiotherapy. Subjects who have had palliative radiotherapy to a peripheral site (e.g., bone metastases) prior to 4 weeks may be admitted to the study, provided they have recovered from any acute adverse events;\n2. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects previously treated for brain metastases may enter the study provided they have stable brain metastases and have not been treated for brain metastases with steroids for at least 28 days prior to study entry. This exception does not include carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability;\n3. Major surgery, open biopsy, or severe trauma 28 days prior to first dose;\n4. Have a previous history of hypersensitivity to fluorouracil or irinotecan;\n5. Subjects with hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)\n6. Subject has uncontrolled cardiovascular clinical symptoms or disease, including but not limited to: (1) New York Heart Association Class II or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically interfered with or remains poorly controlled after clinical intervention.\n7. Clinically significant bleeding symptoms or a definite bleeding tendency within 3 months prior to the first dose, e.g., gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis;\n8. Arterial\u002Fvenous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accidents (including temporary ischaemic attack, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, with superficial venous thrombosis being eligible for enrolment as determined by the investigator;\n9. Have another malignancy that is progressing or requires aggressive treatment, except for non-melanoma skin cancer and cervical cancer in situ for which potential treatment has been administered;\n10. Women who are pregnant or breastfeeding;\n11. Subjects who, in the judgement of the investigator, have other factors that may cause them to be forced to terminate the study midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, grossly abnormal laboratory test values, and family or social factors that may affect the subject's safety or the collection of trial data",{"count":566,"type":22},100,[25],"Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.",[30],"2025-12-15",{"date":572,"type":35},"2025-12-22",{"date":574,"type":35},"2024-11-12",{"date":576,"type":22},"2027-10-31",{"name":578,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":580,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":26,"conditions":584,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":43},"100584459","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. The number of liver metastases is≥3.Besides the ablation lesions,there must be at least one measurable lesion(≥1cm),and the diameter of the ablation lesions is\\\u003C5cm; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received Pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received Pucotenlimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.",{"count":21,"type":22},[25],[28,29,30],"2025-11-18",{"date":587,"type":35},"2025-11-21",{"date":589,"type":35},"2025-11-04",{"date":39,"type":22},{"name":41,"class":42},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"100611755","phase-1-a-study-of-abt-301-plus-tislelizumab-with-bevacizumab-in-pmmrnon-msi-h-locally-advanced-or-mcrc-100611755","NCT07244705","A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR\u002FNon-MSI-H Locally Advanced or mCRC","An Open-label, Multicenter, Phase 1\u002F2 Study Exploring the Safety and Efficacy of ABT-301 in Combination With Tislelizumab and Bevacizumab in Participants With Proficient Mismatch Repair (pMMR)\u002FNon-Microsatellite Instability-High (Non-MSI-H) Locally Advanced or Metastatic Colorectal Cancer (mCRC)","Inclusion Criteria:\n\n* Participant must be ≥18 years at the time of signing the informed consent.\n* Participant with pMMR\u002Fnon-MSI-H advanced\u002Frecurrent histologically confirmed CRC with at least one measurable lesion, per RECIST version 1.1.\n* Participant must have received ≥2 lines of prior systemic therapy (including but not limited to chemotherapeutic agents of 5-fluorouracil, oxaliplatin, irinotecan; participant may or may not have received biologic agents such as cetuximab, panitumumab, aflibercept, ramucirumab, bevacizumab; tyrosine kinase inhibitors of regorafenib, fruquintinib).\n\nNOTE: Participants with BRAF V600E, HER2 amplification\u002F mutation, KRAS G12C mutation, NTRK gene fusion, RET fusion, may or may not have received relevant targeted therapy and failed.\n\n* Participant must submit an archival formalin-fixed, paraffin-embedded tumor specimen collected within 5 years before screening. If archival specimens are unavailable, alternative samples, such as colon endoscopy biopsy, are acceptable.\n\nNOTE: For participants who consent to join the exploratory biomarker study, a fresh biopsy sample is required during the screening and treatment periods. Exceptions may be granted if tumor tissue cannot be obtained due to specific circumstances.\n\n* Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or nonMSI-H by polymerase chain reaction (PCR) (Appendix 13).\n* ECOG Performance Status of 0 or 1.\n* Adequate hematologic and end-organ function, defined by laboratory data obtained within 7 days prior to the first dose of study intervention:\n\n  1. Absolute neutrophil count ≥1.5 × 109\u002FL (1500\u002FμL) without granulocyte colony-stimulating factor support.\n  2. Lymphocyte count \\>0.5 × 109\u002FL (500\u002FµL).\n  3. Platelet count \\>100 × 109\u002FL (100,000\u002FμL), without transfusion.\n  4. Hemoglobin \\>90 g\u002FL (9 g\u002FdL), participants may be transfused to meet this criterion.\n  5. AST, ALT, and ALP \\\u003C2.5 × ULN (must be ≤5 × ULN for participants with liver metastases).\n  6. Total serum bilirubin \\\u003C1.5 × ULN (\\\u003C3 × ULN in the presence of documented Gilbert's syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases at baseline).\n  7. Creatinine clearance \\>60 mL\u002Fmin.\n  8. Serum albumin ≥30 g\u002FL (3 g\u002FdL).\n  9. International normalized ratio (INR) or activated partial thromboplastic time (aPTT) \\\u003C1.5 × ULN.\n  10. Urine dipstick for proteinuria ≤2+ (within seven days prior to the first dose of study intervention).\n* Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤1 prior to study entry, with the exception of Grade ≤2 chemotherapy-related peripheral neuropathy or any Grade alopecia.\n* Participant must have a negative test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.\n\nNOTE: Participants with active hepatitis B virus (HBV) infection are eligible for the study if the following applies: HBV deoxyribonucleic acid (DNA) \\\u003C500 IU\u002FmL within 28 days prior to initiation of study intervention, and anti-HBV treatment (per local standard of care, e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study. Participants with positive hepatitis C virus (HCV) test are eligible for the study if they complete their antiviral therapy prior to study entry.\n\n* Contraceptive use by participants or participant partners must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nNOTE: The reliability of sexual abstinence for male and\u002For female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nMale Participants:\n\nA male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol during the intervention period and for at least 90 days after the last dose of study intervention and refrain from donating sperm during this period.\n\nFemale Participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:\n\no Not a CBP participant as defined in Appendix 4 and below: surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy as confirmed by review of the participant's medical records, medical examination, or medical history interview), or postmenopausal (defined as no menses for 12 months) without an alternative medical cause with follicle-stimulating hormone (FSH) level in the postmenopausal range ≥1 year.\n\nOR\n\no A CBP participant who agrees to follow the contraceptive guidance in Appendix 4 during the intervention period and for at least 180 days after the last dose of study intervention.\n\n\\- Participant is capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* History of leptomeningeal disease.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, or ankylosing spondylitis.\n\nEXCEPTIONS:\n\n* Participants with the following conditions are eligible for the study: autoimmune-related hypothyroidism on thyroid-replacement hormone are eligible for the study. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: 1. Rash must cover \\\u003C10% of body surface area 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids 3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nEXCEPTIONS:\n\no History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\n* Active tuberculosis.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within three months prior to initiation of study intervention, unstable arrhythmia, or unstable angina.\n\nNOTE: Participants are not eligible for the study if they have or are\n\n1. A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds).\n2. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n3. Using concomitant medications that prolong the QT\u002FQTc interval. - Major surgical procedure, other than for diagnosis, within four weeks prior to initiation of study intervention, or anticipation of need for a major surgical procedure during the study.\n\n   * History of malignancy other than CRC within five years prior to screening.\n\n   EXCEPTIONS:\n\n   o Participants with malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer, are eligible for the study.\n\n   \\- Severe infection within four weeks prior to initiation of study intervention, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n\n   \\- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications.\n\n   \\- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n   * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tislelizumab or bevacizumab formulation.\n   * Participant is breastfeeding, has a positive serum pregnancy test at the Screening Visit, or is planning to become pregnant during the study intervention or within at least 120 days after the last dose of study intervention.\n   * Symptomatic, untreated, or actively progressing CNS metastases.\n\n   NOTE: Asymptomatic participants with treated CNS lesions are eligible, provided that all of the following criteria are met:\n   * Measurable disease, per RECIST version 1.1.\n   * Must be present outside the CNS.\n   * The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.\n   * There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study intervention.\n   * The participant has not undergone stereotactic radiotherapy within seven days prior to initiation of study intervention, whole brain radiotherapy within 14 days prior to initiation of study intervention, neurosurgical resection within 28 days prior to initiation of study intervention.\n   * The participant has no ongoing requirement for corticosteroids as therapy for CNS disease.\n\n   NOTE: Anticonvulsant therapy at a stable dose is permitted. Asymptomatic participants with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan.\n   * Uncontrolled tumor-related pain:\n\n\u003C!-- -->\n\n1. Participants requiring pain medication must be on a stable regimen at study entry.\n2. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should recover from the effects of radiation. There is no required minimum recovery period.\n3. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.\n\n   * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).\n   * Treatment with any investigational therapy within 28 days prior to initiation of study intervention.\n   * Treatment with the following pharmaceutical or herbal agents within 14 days prior to initiation of study intervention:\n\n\u003C!-- -->\n\n1. Known to be moderate or strong inhibitors or inducers of CYP3A4 (Appendix 9).\n2. Known to be sensitive or narrow therapeutic index substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 (Appendix 10).\n\n   \\- Prior treatment with any immunotherapy agent, including CD137 agonists or immune checkpoint blockade therapies (such as anti-cytotoxic T-lymphocyte-associated antigen-4 \\[anti-CTLA-4\\], anti-PD-1, and anti-PD-L1 therapeutic antibodies) and has experienced disease progression.\n   * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within two weeks prior to initiation of study intervention, or anticipation of need for systemic immunosuppressive medication during study intervention.\n\n   NOTE: Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor approval has been obtained.\n\n   \\- Inadequately controlled arterial hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg), based on an average of three blood pressure readings on two sessions.\n\n   NOTE: Anti-hypertensive therapy to achieve these parameters is allowable.\n\n   \\- Prior history of hypertensive crisis or hypertensive encephalopathy.\n\n   \\- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within six months prior to initiation of study intervention.\n\n   \\- History of hemoptysis (\\>2.5 mL of bright red blood per episode) within one month prior to initiation of study intervention.\n\n   \\- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n\n   \\- Current or recent (within ten days of first dose of study intervention) use of aspirin (\\>325 mg\u002Fday) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol.\n\n   \\- Current or recent (within ten days prior to initiation of study intervention) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.\n\n   NOTE: Allowable direct oral anticoagulants for prophylaxis include apixaban, edoxaban, rivaroxaban, and dabigatran. Participants should not be on any other anticoagulant for prophylaxis. Participants taking vitamin K antagonists, such as warfarin, are not eligible for the study.\n\n   \\- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within three days prior to the first dose of study intervention.\n\n   \\- History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within six months prior to initiation of study intervention.\n\n   \\- History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction including sub-occlusive disease-related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding within six months prior to initiation of study intervention.\n\n   NOTE: Participants with signs\u002Fsymptoms of sub-\u002Focclusive syndrome\u002Fintestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution.\n\n   \\- Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure.\n   * Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.\n   * Metastatic disease that involves major airways or blood vessels or centrally located mediastinal tumor masses (\\\u003C30 mm from the carina) of large volume.\n   * History of intra-abdominal inflammatory process within 6 months prior to initiation of study intervention, including but not limited to peptic ulcer disease, diverticulitis, or colitis.\n   * Curative radiotherapy within 28 days and abdominal\u002Fpelvic radiotherapy within 60 days prior to initiation of study intervention, except palliative radiotherapy to bone lesions within seven days prior to initiation of study intervention.\n   * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study intervention, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study intervention or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.\n   * Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID). NOTE: Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed. If the Investigator has specific considerations regarding the use of NSAIDs for pain management, it should be discussed with the Sponsor on a case-by-case basis.\n   * Participant cannot swallow oral medications or have a GI illness that may clinically significantly affect the absorption of ABT-301 (e.g., chronic diarrhea with malabsorption).",{"count":5,"type":22},[76,25],"The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg\u002Fkg IV infusion Q3W, in participants with pMMR\u002Fnon-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301.\n\nParticipants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg\u002Fkg IV Q3W will be given in both parts of the study.",[603,30,365,135],"Colorectal Cancer (Diagnosis)",{"date":605,"type":35},"2025-11-24",{"date":607,"type":22},"2025-11",{"date":609,"type":22},"2028-07",{"name":611,"class":89},"Anbogen Therapeutics, Inc.",15,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":623,"conditions":624,"keywords":626,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":261},"100543283","prospective-national-cohort-evaluating-predictive-biomarkers-of-resistance-to-immunotherapy-in-patients-with-msidmmr-metastatic-colorectal-cancer-coresim-100543283","NCT06353854","Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI\u002FdMMR Metastatic Colorectal Cancer (CORESIM)","National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer","CORESIM","Inclusion Criteria:\n\n* Patients over 18 years old\n* Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab\n* Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and\u002For PMS2) and\u002For by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center)\n\nExclusion Criteria:\n\n* Patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team.\n* Previous treatment with anti-PD1 or anti-PDL1.\n* Previous treatment with chemotherapy +\u002F- targeted therapy for MSI\u002FdMMR metastatic colorectal cancer.\n* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons).\n* Pregnant women\n* persons under court protection or under protective supervision (guardianship or curatorship)\n* Opposition to participation in the study.",{"count":622,"type":22},600,"The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +\u002F- targeted therapy in first-line treatment of dMMR\u002FMSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR\u002FMSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.",[30,625],"Microsatellite Instability-High Colorectal Cancer",[627],"immunotherapy resistance","2025-10-01",{"date":630,"type":35},"2025-10-06",{"date":632,"type":35},"2024-02-12",{"date":634,"type":22},"2030-02-12",{"name":636,"class":42},"Federation Francophone de Cancerologie Digestive"]