Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05970302
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '2 years', 'description': 'ORR of regimen of XELOX +Bev +Tislelizumab'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR)', 'timeFrame': '2 years'}, {'measure': 'Disease Control Rate (DCR);', 'timeFrame': '2 years'}, {'measure': 'Median Progression-Free Survival (mPFS)', 'timeFrame': '2 years'}, {'measure': '12-month PFS rate', 'timeFrame': '12 months'}, {'measure': 'Median Overall Survival (mOS)', 'timeFrame': '5 years'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '2 years', 'description': 'Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single-arm', 'Phase II'], 'conditions': ['Tislelizumab', 'Bevacizumab', 'Oxaliplatin', 'Capecitabine', 'MSS/pMMR', 'Metastatic Colorectal Cancer (mCRC)', 'RAS-mutated', 'First-Line']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS/pMMR-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed initially unresectable MSS/pMMR-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/L and neutrophils ≥ 1.5\\*10\\^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100\\* 10\\^9/L; 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 \\<2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml/min; 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 (\\< 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/PD-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/ulcers 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/day 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)."}, 'identificationModule': {'nctId': 'NCT05970302', 'briefTitle': 'XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS/pMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.', 'orgStudyIdInfo': {'id': 'NCC-009591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XELOX +Bev +Tislelizumab', 'description': 'Every 3 weeks as a cycle:\n\n1. Tislelizumab: 200mg, iv, d1;\n2. Bevacizumab: 7.5mg/kg, iv, d1;\n3. Oxaliplatin: 130mg/m2, iv, d1;\n4. Capecitabine: 1000mg/m2, 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.', 'interventionNames': ['Drug: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine']}], 'interventions': [{'name': 'Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine', 'type': 'DRUG', 'description': 'Use the above medications on a regular basis.', 'armGroupLabels': ['XELOX +Bev +Tislelizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lin yang', 'role': 'CONTACT', 'email': 'linyangcicams@126.com', 'phone': '13611267380'}], 'facility': 'Lin Yang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'LIN YANG', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}