[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513809":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":69,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"XELOX +Bev +Tislelizumab","EXPERIMENTAL","Every 3 weeks as a cycle:\n\n1. Tislelizumab: 200mg, iv, d1;\n2. Bevacizumab: 7.5mg\u002Fkg, iv, d1;\n3. Oxaliplatin: 130mg\u002Fm2, iv, d1;\n4. Capecitabine: 1000mg\u002Fm2, bid, po, d1-d14; Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is capecitabine + BEV combined with tislelizumab.",[13],"Drug: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine","Use the above medications on a regular basis.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Lin Yang","RECRUITING","Beijing","China","CN",{"type":29,"coordinates":30},"Point",[31,32],116.39723,39.9075,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"lin yang","CONTACT","13611267380","linyangcicams@126.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","LIN YANG","chief physician","100513809","phase-2-xelox-bev-tislelizumab-for-first-line-treatment-of-msspmmr-ras-mutated-mcrc-100513809",false,"NCT05970302","XELOX +Bev +Tislelizumab for First-line Treatment of MSS\u002FpMMR RAS-mutated mCRC","XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS\u002FpMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.","Inclusion Criteria:\n\n1. Histologically confirmed initially unresectable MSS\u002FpMMR-type RAS-mutant metastatic colorectal adenocarcinoma;\n2. ECOG score of 0 or 1;\n3. Ability to swallow oral medications;\n4. Have at least one measurable lesion (according to RECIST v1.1 standard);\n5. No anti-tumor treatment has been received after recurrence and metastasis;\n6. Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months;\n7. Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5\\*10\\^9\u002FL and neutrophils ≥ 1.5\\*10\\^9\u002FL, hemoglobin ≥ 90g\u002FL, platelets ≥ 100\\* 10\\^9\u002FL; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; Urinary protein \\\u003C2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml\u002Fmin; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);\n8. Expected survival period ≥ 3 months;\n9. Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;\n10. Women with reproductive potential (\\\u003C 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.\n\nExclusion Criteria:\n\n1. Previously received bevacizumab or anti-CTLA4, anti-PD-1\u002FPD-L1 therapeutic antibodies or pathway-targeted drugs;\n2. Received radiotherapy within 4 weeks before the evaluation;\n3. Symptomatic peripheral neuropathy \\> grade 2 (CTCAE5.0 standard);\n4. Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;\n5. HIV-positive and other immunodeficiency diseases;\n6. Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA is negative by PCR);\n7. Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia areata); inhaled or topical steroids or equivalent steroids in excess of 10 mg prednisone per day, except for inactive autoimmune disease on adrenal replacement therapy;\n8. Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily application of more than 10 mg prednisone, etc. Except for inactive autoimmune diseases treated with adrenal replacement therapy with potent steroids;\n9. Have a history of organ transplantation;\n10. Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;\n11. Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or may need major surgery during the study period;\n12. Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 1 year, and there is no clinical and imaging evidence of recurrence or progression except);\n13. Combined active and refractory infection;\n14. Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of NYHA ≥ 2 (CHF), uncontrolled arrhythmia; uncontrolled hypertension; thromboembolic or bleeding events within 6 months before treatment;\n15. Evidence of causing coagulation disease;\n16. With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as Crohn's disease or ulcerative colon inflammation);\n17. Severe unhealed wounds\u002Fulcers or severe fractures;\n18. Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;\n19. There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;\n20. Pregnant or lactating women;\n21. No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg\u002Fday allowed);\n22. Severe allergic reaction to the test drug;\n23. Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).","ALL","18 Years",{"count":54,"type":55},52,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS\u002FpMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a \"hot tumor\" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.",[61,62,63,64,65,66,67,68],"Tislelizumab","Bevacizumab","Oxaliplatin","Capecitabine","MSS\u002FpMMR","Metastatic Colorectal Cancer (mCRC)","RAS-mutated","First-Line",[70,71],"Single-arm","Phase II","2023-07-21",{"date":74,"type":75},"2023-08-01","ACTUAL",{"date":77,"type":75},"2023-07-07",{"date":79,"type":55},"2026-07",{"name":5,"class":6},1]