[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-metastatic-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-metastatic-colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,69,101,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100565489","phase-3-bevacizumab-based-chemotherapy-adapted-to-bevacizumab-pharmacokinetics-in-1st-line-treatment-100565489",false,"NCT06642844","Bevacizumab-based Chemotherapy Adapted to Bevacizumab Pharmacokinetics in 1st-line Treatment","Bevacizumab-based Chemotherapy Tailored to the Pharmacokinetics of Bevacizumab in First-line Treatment of Unresectable Metastatic Colorectal Cancer: a Randomized, Multicenter, Double-blind Phase 3 Study","PHARBEVACOL","Inclusion Criteria:\n\n* Patients aged ≥18 years.\n* Histologically proven metastatic colorectal adenocarcinoma (on primary tumor and\u002For metastases) inoperable, well documented, i.e. not compatible with complete oncological resection at inclusion.\n* For whom treatment with bevacizumab is indicated.\n* For women of childbearing age: effective contraception.\n* ECOG Performance status (PS) 0-2.\n* No prior treatment of metastatic disease (in the case of adjuvant treatment, interval between the end of chemotherapy and relapse \\> 6 months if fluoropyrimidine alone or \\> 12 months if FOLFOX).\n* At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria.\n* Life expectancy greater than 3 months.\n* Adequate hematological, renal and hepatic biological parameters: neutrophils ≥ 1.5x109\u002FL; platelets ≥ 100x109\u002FL; hemoglobin ≥ 9 g\u002FdL; serum creatinine \\\u003C150 μmol\u002FL; bilirubinemia ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase \\\u003C 5xULN; proteinuria \\\u003C 2+ (urine dipstick) or ≤ 1 g\u002F24h.\n* Written informed consent signed by the patient.\n* Patient affiliated to a French social security system.\n\nRandomization criteria in the experimental phase:\n\n\\- Serum concentration of bevacizumab on D14 ≤ 15.5 mg\u002FL (measured just before the 2nd infusion of bevacizumab).\n\nExclusion Criteria:\n\nLess than 6 months from the end of any prior chemotherapy, radiotherapy or adjuvant surgery.\n\n* Patient with a known non-indication or contraindication to first-line chemotherapy based on bevacizumab.\n* Cardiovascular contraindication to the prescription of bevacizumab: heart failure, cardiovascular event within 6 months, NYHA ≥ 2 (New York Heart Association), poorly controlled arterial hypertension, history of hypertensive crisis or hypertensive encephalopathy; Grade 3\u002F4 anterior venous thromboembolism (NCI-CTCAE)\n* Inadequate hematological, hepatic and renal function\n* Urine test strip for proteinuria ≥ 2+ unless proteinuria \\\u003C 1 g \u002F 24 hours is demonstrated.\n* Current or recent (within 10 days of study enrollment) use of aspirin (\\>325 mg\u002Fday) or clopidogrel (\\>75 mg\u002Fday).\n* Current or recent use (within 10 days before the first dose of bevacizumab) of oral or parenteral therapeutic anticoagulants or thrombolytic agents for therapeutic purposes.\n* Untreated CNS metastases or treatment of brain metastases, either by surgical or radiological techniques, must have been completed more than 4 weeks before the first study treatment.\n* Surgical procedure (including open biopsy, surgical resection, wound revision, or other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to study enrollment or anticipation of study need for major surgery during the study.\n* Serious non-healing wound, active ulcer or untreated bone fracture.\n* Other neoplasias (previous or current), except:\n\n  * i\u002F carcinoma in situ of the cervix adequately treated,\n  * ii\u002F basal cell or squamous cell carcinoma of the skin,\n  * iii\u002F cancer in complete remission for more than 5 years.\n* Other illnesses, which, according to the doctor, are life-threatening to the patient and\u002For which are uncontrolled.\n* Primary tumor in place and symptomatic (occlusion, hemorrhage).\n* Pregnant or breastfeeding women.\n* Patients unable to give consent.\n* Patients under guardianship, curatorship or legal protection.","ALL","18 Years","99 Years",{"count":21,"type":22},244,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Bevacizumab is a standard drug for metastatic colorectal cancer (mCRC) in combination with cytotoxic chemotherapy. However, inter-individual pharmacokinetic variability was observed for bevacizumab and an exposure-response relationship for efficacy was described for bevacizumab in mCRC patients treated with 1st-line bevacizumab-based chemotherapy.",[28],"Unresectable Metastatic Colorectal Cancer","RECRUITING","2026-06-12",{"date":32,"type":33},"2026-06-16","ACTUAL",{"date":35,"type":33},"2025-03-04",{"date":37,"type":22},"2029-03-04",{"name":39,"class":40},"University Hospital, Tours","OTHER",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100587911","phase-1-first-in-human-trial-of-stc-1010-an-immunotherapy-in-patients-with-unresectable-locally-advanced-or-metastatic-colorectal-cancer-100587911","NCT06934538","First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer","Open Label, Multicenter, Dose-escalation and Cohort-expansion Phase I\u002FIIA Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (CRC) - BreAK CRC Trial (BreAK for Brenus Anti-cancer)","Inclusion Criteria:\n\n1. Male or female aged 18-75 years\n2. Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum\n3. Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant treatment and first relapse\n4. Determination of KRAS and BRAF mutation status\n5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n6. Must agree to have biopsy at screening and on-treatment, only if not representing an unacceptable clinical risk and\u002For if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants \\>70 years must have a PS= 0.\n8. Life expectancy \\> 3 months as assessed by the investigator\n9. Effective contraceptive measures implemented\n\nExclusion Criteria:\n\n1. Patients with symptomatic ascites or pleural effusion\n2. Dihydropyrimidine dehydrogenase (DPD) deficiency\n3. Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability\n4. Prior chemotherapy for metastatic disease\n5. Prior immunotherapy for advanced\u002Fmetastatic disease (except for Arm 2A-2)\n6. Prior therapy with an investigational agent\n7. BRAF mutation\n8. Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis\n9. Medical conditions requiring immunosuppressive therapy\n10. Major surgery \\\u003C4 weeks prior to first administration of STC-1010\n11. Radiotherapy \\\u003C 4 weeks prior to first administration of STC-1010 or \\\u003C 2 weeks in case of palliative radiotherapy\n12. Prior stem cell or solid organ transplantation\n13. Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent\n14. Active drug or alcohol abuse as assessed by the Investigator\n15. Participant deprived of their liberty by a judicial or administrative decision, undergoing psychiatric care and admitted to a health or social establishment for purposes other than research.","75 Years",{"count":51,"type":22},90,[53,54],"PHASE1","PHASE2","This is a phase I\u002FIIA, first-in-human (FIH), two-part, open-label, multicenter study to characterize the safety, tolerability profile, and clinical efficacy of STC-1010 associated with GM-CSF and cyclophosphamide immunostimulant (IS) regimen administered with standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab) to participants with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) colorectal cancer (CRC).\n\nThe trial will be conducted in two parts:\n\n* A Phase I consisting of a dose escalation part and small expansion part to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D) and safety profile of the STC-1010 + IS regimen administered with SOC therapy. Approximately 21 to 33 participants will be included in this phase in Europe.\n* A Phase IIA consisting of the expansion stage of the study which will further evaluate the clinical efficacy and safety of STC-1010 on a larger number of participants treated at the identified RP2D. Approximately 57 to 60 participants will be enrolled in total in 2 different arms. Multi-site recruitment will take place in Europe and in the US.",[28,57],"Unresectable Locally Advanced Colorectal Cancer","2025-12-19",{"date":60,"type":33},"2025-12-22",{"date":62,"type":33},"2025-06-17",{"date":64,"type":22},"2029-06",{"name":66,"class":67},"Brenus Pharma","INDUSTRY",9,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100580275","phase-2-sbrt-combined-with-capeox-bevacizumab-and-pd-1-inhibitor-for-the-treatment-of-ras-mutant-mss-type-unresectable-metastatic-colorectal-cancer-100580275","NCT06835179","SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.","Evaluation of the Efficacy and Safety of SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, MSS-Type, and Unresectable Metastatic Colorectal Cancer: a Single-center, Single-arm, Open-label Clinical Trail.","Inclusion Criteria:\n\n* Aged 18-75 years, regardless of gender.\n* Lower edge of the lesion located ≥12 cm from the anal verge.\n* Histologically confirmed colorectal adenocarcinoma.\n* Confirmed as unresectable by multidisciplinary team (MDT) evaluation.\n* RAS mutation-positive.\n* Microsatellite\u002Fmismatch repair status: MSS\u002FpMMR.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected survival ≥3 months.\n* Adequate hematological, hepatic, and renal function:\n\nNeutrophil count ≥1.5 × 10⁹\u002FL; Platelet count ≥75 × 10⁹\u002FL; Serum total bilirubin ≤1.5 × upper normal limit (UNL); Aspartate aminotransferase (AST) ≤2.5 × UNL; Alanine aminotransferase (ALT) ≤2.5 × UNL; Serum creatinine ≤1.5 × UNL.\n\n* Karnofsky Performance Status (KPS) score ≥70.\n* Adequate organ function with no contraindications to surgery, radiotherapy, chemotherapy, or immunotherapy.\n* No prior chemotherapy or other antitumor therapy before enrollment.\n* No prior immunotherapy received.\n* Willingness and ability to comply with the study protocol during the trial period.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients who have received antibodies against programmed death receptor-1 (PD-1) or its ligand (PD-L1), as well as antibodies against cytotoxic T lymphocyte associated antigen 4 (CTLA-4).\n* Patients with any active autoimmune diseases or a history of requiring steroid or immunotherapy treatment.\n* Complex situations with concurrent active bleeding, perforation, or requiring emergency surgery.\n* Have received systemic anti-cancer treatment for rectal cancer.\n* Simultaneously present with other non colorectal cancer tumor diseases.\n* Patients with interstitial lung disease, non infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).\n* Any grade 2 or above toxic reactions (classified according to the Common Terminology Criteria for Adverse Events (CTCAE) 5th edition) caused by previous treatment that have not subsided (excluding anemia, hair loss, and skin pigmentation).\n* Pregnant or lactating women.\n* Patients who are known or have been tested for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n* Known or suspected history of allergies to any relevant drugs used in the trial",{"count":77,"type":22},28,[54],"SBRT Combined with CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, Microsatellite Stable (MSS), Unresectable Metastatic Colorectal Cancer (mCRC): a Single-center, Single-arm, Open-label Clinical Trail",[28,81,82],"Microsatellite Stable (MSS) Colorectal Cancer (CRC)","RAS-mutant Colorectal Cancer",[84,85,86,87,88,89,90],"SBRT","CAPEOX","Bevacizumab","PD-1 Inhibitor","RAS-Mutant","Microsatellite Stable (MSS)","Unresectable Metastatic Colorectal Cancer (mCRC)","NOT_YET_RECRUITING","2025-02-16",{"date":94,"type":33},"2025-02-19",{"date":96,"type":22},"2025-02",{"date":98,"type":22},"2027-05",{"name":100,"class":40},"The First Affiliated Hospital with Nanjing Medical University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":5},"100438643","phase-1-study-of-pembrolizumab-treatment-after-cyad-101-with-folfox-preconditioning-in-metastatic-colorectal-cancer-100438643","NCT04991948","Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer","An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer","Key Inclusion Criteria:\n\n1. Histologically proven metastatic adenocarcinoma of the colon or rectum.\n\n   1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.\n   2. Confirmed non-microsatellite instability high (non-MSI-H)\u002Fmismatch-repair proficient (pMMR) tumor status\n   3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n   4. Recurrent\u002Fprogressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy\n   5. The patient is due to receive FOLFOX chemotherapy\n   6. Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. Adequate organ, hepatic, renal, pulmonary and cardiac functions\n4. Tumor biopsy at screening\n\nKey Exclusion Criteria:\n\n1. Any other investigational agent or device within 4 weeks of the first study treatment administration.\n2. Any anticancer agent within 4 weeks of the first study treatment administration\n3. Filgrastim (Granulocyte-Colony-Stimulating Factor \\[G-CSF\\]) or similar growth factors within 7 days of the first study treatment administration\n4. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor\n5. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration\n6. Major surgery within 4 weeks before the planned day for the first study treatment administration\n7. A live vaccine within 30 days prior to the planned day for the first study treatment administration\n8. Uncontrolled intercurrent illness or serious uncontrolled medical disorder\n9. Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.",{"count":109,"type":22},34,[53],"The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.",[28],"2022-02-22",{"date":115,"type":33},"2022-03-09",{"date":117,"type":33},"2021-11-22",{"date":119,"type":22},"2038-05-25",{"name":121,"class":67},"Celyad Oncology SA",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":41},"100338895","phase-1-alloshrink---standard-chemotherapy-regimen-and-immunotherapy-with-allogeneic-nkg2d-based-cyad-101-chimeric-antigen-receptor-t-cells-100338895","NCT03692429","alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells","An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer","alloSHRINK","Inclusion Criteria:\n\n1. Histologically proven metastatic adenocarcinoma of the colon or rectum.\n\n   1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.\n   2. Recurrent\u002Fprogressing disease after at least one line of systemic therapy for metastatic disease.\n   3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n   4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.\n   5. FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized.\n2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.\n\nExclusion Criteria:\n\n1. The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).\n2. Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.\n3. Filgrastim (Granulocyte-Colony-Stimulating Factor \\[G-CSF\\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.\n4. Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.",{"count":131,"type":22},49,[53],"The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy",[28],"2020-11-19",{"date":137,"type":33},"2020-11-20",{"date":139,"type":33},"2018-11-28",{"date":141,"type":22},"2036-02-17",{"name":121,"class":67}]