[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cetuximab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cetuximab":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631855","phase-2-a-phase-ii-study-of-sintilimab-combined-with-ipilimumab-n01-cetuximab-and-dabrafenib-in-patients-with-microsatellite-stable-braf-v600e-mutated-metastatic-colorectal-cancer-100631855",false,"NCT07506109","A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Provided written informed consent.\n2. Age ≥ 18 years.\n3. Histologically or pathologically confirmed colorectal adenocarcinoma.\n4. Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.\n5. Locally advanced unresectable disease or distant metastasis.\n6. No prior treatment with BRAF\u002FMEK\u002FERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).\n7. Presence of measurable target lesions per RECIST 1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n9. Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL.\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm³ (≥ 1.5 × 109\u002FL).\n   3. Platelet count ≥ 80,000\u002Fmm³ (≥ 80 × 109\u002FL).\n   4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n10. Willing and able to comply with study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.\n2. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis\u002Fdrainage).\n3. Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 3 years).\n4. Presence of severe comorbidities or serious medical conditions.\n5. Pregnant or breastfeeding females.\n6. The investigator deems the patient unsuitable for participation in this study.","ALL","18 Years",{"count":18,"type":19},49,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1\u002FPD-L1 inhibition.\n\nPreclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF\u002FEGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy.\n\nThis is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.",[25,26,27,28,29,30,31],"BRAF V600E","Colorectal Cancer","Sintilimab","MSS (Microsatellite Stable)","Cetuximab","Dabrafenib","Ipilimumab N01","RECRUITING","2026-04-01",{"date":35,"type":36},"2026-04-07","ACTUAL",{"date":38,"type":36},"2026-03-01",{"date":40,"type":19},"2028-06",{"name":42,"class":43},"Tianjin Medical University Cancer Institute and Hospital","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100612751","phase-2-the-safety-and-efficacy-of-cetuximab-beta-plus-fruquintinib-with-or-without-immune-checkpoint-inhibitorrs-in-first-line-treatment-of-rasbraf-wild-type-unresectable-metastatic-colorectal-cancer-100612751","NCT07257653","The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS\u002FBRAF Wild Type Unresectable Metastatic Colorectal Cancer","concept","Inclusion Criteria:\n\n1）Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1. For patients aged 80-85, comprehensive functional assessments must be completed, and they may be enrolled if the investigator deems them tolerable, with an expected survival of over 3 months; 3) Histopathologically and\u002For cytologically confirmed, unresectable metastatic colorectal adenocarcinoma confirmed by MDT discussion (UICC\u002FAJCC TNM staging system for colorectal cancer, 8th Edition, 2017); 4) At least one measurable lesion confirmed according to RECIST 1.1 criteria; 5) Adequate function of major organs, meeting the following criteria:\n\n1. Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):\n\n   1. Hemoglobin (HGB) ≥ 90 g\u002FL;\n   2. Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL;\n   3. Platelet count (PLT) ≥ 75 × 10⁹\u002FL;\n2. Biochemical tests must meet the following criteria:\n\n   1. Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Gilbert's syndrome);\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If with liver metastases, ALT and AST ≤ 5 × ULN;\n   3. Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 50 ml\u002Fmin.\n3. Coagulation function or thyroid function tests must meet the following criteria:\n\n   1. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);\n   2. Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed (FT3 and FT4 may be substituted if T3\u002FT4 are unavailable at the center). Subjects may be enrolled if T3 and T4 levels are normal.\n4. Echocardiogram assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Hepatitis B surface antigen (HBsAg) negative. If HBsAg positive, hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \\\u003C 2500 copies\u002FmL or 500 IU\u002FmL for enrollment.\n6. HCV antibody negative or HCV-RNA negative subjects may enroll; if HCV-RNA positive, subjects must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN to enroll. Subjects with co-infection of hepatitis B and hepatitis C are excluded (positive for HBsAg or HBcAb, and positive for HCV antibody).\n7. Female patients must meet one of the following conditions:\n\n   1. Postmenopausal (defined as no menses for at least 1 year, with no other confirmed causes besides menopause), or\n   2. Surgically sterilized (removal of ovaries and\u002For uterus), or\n   3. Of childbearing potential but must meet the following:\n\n      * Serum\u002Furine pregnancy test within 7 days prior to enrollment must be negative;\n      * Agree to use contraception with a failure rate of \\\u003C 1% per year or maintain abstinence (avoiding heterosexual intercourse) (from signing the ICF until at least 6 months after the last dose of the study drug) (contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, copper intrauterine devices, or condoms);\n      * Must not be breastfeeding.\n8. Male patients must meet the following: Agree to abstinence (avoiding heterosexual intercourse) or use contraception, as specified: When the partner is a woman of childbearing potential or is pregnant, the male patient must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose to prevent fetal drug exposure. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Presence of MSI-H\u002FdMMR patients.\n2. Concurrent diseases and medical history:\n\n   1. Diagnosis of or concurrent other malignancies within the past 3 years. The following conditions are eligible for enrollment:\n\n      Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\];\n   2. Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n   3. History or tendency of gastrointestinal bleeding or perforation within 4 weeks prior to enrollment;\n   4. Patients with active inflammatory bowel disease within 4 weeks prior to enrollment;\n   5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n   6. Unresolved toxicities from any prior antitumor therapy exceeding CTCAE Grade 1 (excluding alopecia and oxaliplatin-induced neurotoxicity ≤ Grade 2);\n   7. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (excluding gastrointestinal endoscopic biopsy);\n   8. Symptoms of active bleeding within 1 week prior to screening, without significant improvement or control;\n   9. Patients with any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to study initiation, or presence of unhealed wounds, ulcers, or fractures;\n   10. Arterial\u002Fvenous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n   11. History of psychoactive drug abuse with inability to abstain;\n   12. Patients with any severe and\u002For uncontrolled diseases, including:\n\n       * Uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after standard antihypertensive therapy);\n       * Myocardial ischemia ≥ Grade 2, myocardial infarction, arrhythmias (including QTc ≥450 ms for males, QTc ≥470 ms for females), and congestive heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification);\n       * Active or uncontrolled severe infections (≥ CTCAE Grade 2 infection);\n       * Liver cirrhosis, active hepatitis\\*; (\\*Active hepatitis \\[Hepatitis B reference: HBsAg positive and HBV DNA positive (\\>2500 copies\u002FmL or \\>500 IU\u002FmL); Hepatitis C reference: HCV antibody positive and HCV viral titer above the upper limit of normal\\]. Note: Eligible HBsAg-positive or HBcAb-positive subjects and hepatitis C patients require continuous antiviral therapy to prevent viral reactivation.)\n       * Renal failure requiring hemodialysis or peritoneal dialysis;\n       * History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n       * Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL);\n       * Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein quantification \\>1.0 g;\n       * History of clear neurological or psychiatric disorders, including epilepsy or dementia requiring treatment.\n   13. Patients with known active or suspected autoimmune diseases. Patients with immune-related hypothyroidism requiring thyroid hormone replacement therapy and well-controlled type I diabetes are allowed. Patients with vitiligo requiring no intervention or resolved childhood asthma\u002Fallergies requiring no intervention in adulthood are allowed.\n\n       * Receipt of live vaccines within 28 days prior to enrollment. However, inactivated viral vaccines for seasonal influenza are permitted, while live attenuated influenza vaccines administered intranasally are not allowed.\n       * Patients requiring systemic glucocorticoids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive drugs within 14 days prior to enrollment or during the study. The following conditions are allowed for enrollment:\n       * Use of topical or inhaled glucocorticoids in the absence of active autoimmune diseases;\n       * Adrenal glucocorticoid replacement therapy at doses ≤10 mg\u002Fday prednisone equivalent.\n   14. Participation in other clinical studies or initiation of study treatment within 14 days after the end of prior clinical study treatment. History of severe allergy to any monoclonal antibody.\n3. Tumor-related symptoms and treatment:\n\n   1. Surgery (excluding prior diagnostic biopsies), radiotherapy, chemotherapy, or other anticancer therapies within 4 weeks prior to the start of study treatment (calculated from the end date of the last treatment as the washout period);\n   2. Prior postoperative adjuvant therapy containing anti-angiogenic targeted drugs (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, etc.);\n\n   d) Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months;\n4. Patients deemed by the investigator to have concomitant diseases that seriously endanger subject safety or affect study completion, or who are otherwise considered unsuitable for enrollment.","10 Years","85 Years",{"count":55,"type":19},70,[22],"Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer. The inclusion of anti-EGFR or anti-VEGF targeted therapies has improved the overall survival of advanced colorectal cancer patients from 13 months in the era of fluorouracil monotherapy to the current 30 months.\n\nHowever, many patients refuse chemotherapy or cannot tolerate cytotoxic chemotherapeutic drugs, which often leads to poor prognosis in advanced colorectal cancer. Thus, in the treatment of advanced colorectal cancer, is it possible to achieve antitumor activity through the combination of targeted drugs while avoiding chemotherapy?\n\nEarly clinical studies evaluated the possibility of combining anti-EGFR and anti-VEGF monoclonal antibodies. Subsequent large-scale Phase III clinical studies, such as PACCE , indicated that the combination of FOLFOX or FOLFIRI regimens with bevacizumab and panitumumab increased adverse reactions without providing survival benefits in the overall colorectal cancer population compared to the control group. Following this, the CAIRO2 clinical study added cetuximab to CapeOX combined with bevacizumab and still did not demonstrate survival benefits in the first-line treatment of advanced colorectal cancer, particularly in patients with RAS mutations. However, subgroup analyses suggested a certain survival advantage in patients with wild-type RAS who received combined targeted therapy. A recent clinical study (ECOG-ACRIN E7208) showed that in patients with KRAS wild-type advanced colorectal cancer, second-line use of irinotecan combined with cetuximab and ramucirumab significantly improved progression-free survival (PFS) and disease control rate (DCR) compared to cetuximab combined with irinotecan. These studies suggest that combining anti-EGFR and anti-VEGF monoclonal antibodies is a feasible approach for patients with wild-type RAS\n\nCertainly, in terms of anti-VEGF options, besides macromolecular anti-VEGFR monoclonal antibodies, small-molecule tyrosine kinase inhibitors targeting VEGF have also demonstrated significant antitumor activity in colorectal cancer. Studies have shown that fruquintinib significantly prolongs the survival of patients with advanced colorectal cancer, leading to its approval as a third-line treatment for colorectal cancer.\n\nOn the other hand, immunotherapy targeting PD-1 and CTLA-4 has recently made significant progress in the treatment of colorectal cancer. For the pMMR type, which accounts for over 90% of advanced colorectal cancer cases, related clinical studies have confirmed that the combination of immunotherapy and targeted therapy has significant antitumor synergistic effects. These studies also indicate that immune checkpoint inhibitors can enhance the antitumor activity of anti-EGFR and anti-VEGF targeted therapies in pMMR advanced colorectal cancer.\n\nThis study aims to evaluate the efficacy and safety of cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors, as a first-line treatment for pMMR, RAS\u002FBRAF wild-type metastatic colorectal cancer.",[59,60,61,62,63],"Colorectal Neoplasms","RAS","BRAF","Cetuximabβ","Fruquintinib",[65,66,67,68,69],"Colorectal cancer","Chemotherapy-free","KRAS\u002FNRAS\u002FBRAF wild-type","cetuximab combined with fruquintinib","with or without immune checkpoint inhibitors","2025-11-20",{"date":72,"type":36},"2025-12-02",{"date":74,"type":36},"2025-10-21",{"date":76,"type":19},"2027-12-31",{"name":78,"class":43},"Zhejiang University",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":79},"100563445","phase-3-first-line-treatment-of-mcapox--cetuximab-vs-mfolfox6--cetuximab-for-rasbraf-wild-type-mss-unresectable-left-sided-mcrc-a-multicenter-randomized-controlled-phase-iii-study-100563445","NCT06616259","First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS\u002FBRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study","First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS\u002FBRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study","CAPCET-III","Inclusion Criteria:\n\n* Able to provide written informed consent and can understand and comply with the requirements of the study.\n* Men and women ≥ 18 years of age.\n* Patients with histologically or cytologically confirmed RAS and BRAF wild-type, MSS\u002FpMMR, metastatic left-sided colorectal adenocarcinoma.\n* Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.\n* With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy.\n* According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) .\n* Requirements for lab indicators: neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 75 × 10\\^9\u002FL, hemoglobin ≥ 8 g\u002FdL; total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and\u002For ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \\< 1500 U\u002FL; creatinine clearance (calculated according to Cockcroft and Gault formula) \\> 50 mL\u002Fmin or serum creatinine ≤ 1.5 × UNL.\n\nExclusion Criteria:\n\n* Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.\n* Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry\n* Hypersensitivity to any therapeutic agent.\n* Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study.\n* Patients who have failed one or more palliative chemotherapy regimens.\n* Patients with uncontrolled hepatitis B virus.\n* Peripheral neuropathy ≥ CTC grade 2.\n* Neurological or psychiatric disorders affecting cognitive performance.\n* Patients with central nervous system metastasis could not be controlled with radiotherapy.\n* Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation.\n* Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.\n* Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures.\n* History of other malignancies, but no disease-free survival longer than 5 years.\n* Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials.\n* Patients who are unable to comply with this study for psychological, family or social reasons.\n* Patients with other serious diseases that the investigator considers not suitable.",{"count":89,"type":19},452,[91],"PHASE3","This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS\u002FBRAF wild-type, MSS, Unresectable Left-Sided mCRC.",[94,95,29],"Colorectal Cancer (CRC)","Capecitabine",[86],"NOT_YET_RECRUITING","2024-09-24",{"date":100,"type":36},"2024-09-27",{"date":102,"type":19},"2024-09-26",{"date":104,"type":19},"2029-09-30",{"name":106,"class":43},"Meng Qiu"]