metastatic colorectal cancer
Conditions
Interventions
Experimental group:Receive short-course radiotherapy (25 Gy/5 fractions) to the primary tumor site, followed sequentially within 2 weeks post-radiotherapy with QL1706 (5 mg/kg, IV, Q3W) + CAPOX regime
capecitabine, 1000 mg/m2, orally, twice daily, days 1–14) + bevacizumab (7.5 mg/kg, IV, d1) until disease progression (PD), occurrence of intolerable toxicity, initiation of new antitumor therapy, wit
Sponsors
Fujian Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–70 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 3. Pathologically or histologically confirmed MSS/pMMR colorectal adenocarcinoma; 4. Imaging-confirmed stage IIIB-IV colorectal cancer (2018 AJCC Cancer Staging Manual, 8th Edition), excluding patients with T3 stage in the transverse or sigmoid colon; 5. No clinical symptoms of intestinal obstruction, perforation, or bleeding at the primary tumor site; 6. Sufficient tumor tissue obtained via colonoscopic biopsy for MSI, TMB, and other testing; 7. Investigator-assessed life expectancy of at least 3 months; 8. No contraindications to radiotherapy, chemotherapy, or immunotherapy; 9. Subjects must provide informed consent prior to trial initiation, voluntarily sign a written informed consent form, and be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures; 10. Pre-study blood counts and biochemical parameters meet the following criteria: Neutrophils >= 1.5 × 10?/L, Hemoglobin >= 90 g/L, Platelets >= 100 × 10?/L, Prothrombin time = 2+ or 24-hour urine protein >= 1.0 g/24h. (For liver metastases, modified criteria: platelets >= 80 × 10?/L, ALT = 5 ULN, AST <= 5 ULN, total bilirubin <= 2.5 ULN) . 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use reliable and effective contraception during the trial and for 5 months after the last dose. Male subjects with female partners of childbearing potential must agree to use reliable and effective contraception during the trial and for 5 months after the last dose. Breastfeeding women are excluded.
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy, surgery, or other antitumor treatments for colorectal cancer; 2. Previous radiation therapy to the proposed radiotherapy site; 3. History of malignancies other than colorectal cancer within 5 years prior to enrollment (excluding cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with curative therapy, ductal carcinoma in situ treated with curative therapy, etc.); 4. Active autoimmune disease requiring systemic therapy (i.e., immunomodulatory agents, corticosteroids, or immunosuppressive drugs) within the past 2 years; however, replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment and is permitted; 5. Immunodeficiency or ongoing long-term systemic steroid therapy (daily dose exceeding 10 mg prednisone or equivalent glucocorticoid) or other immunosuppressive therapy within 7 days prior to enrollment; 6. Current severe cardiac disease (e.g., heart failure or arrhythmia), renal insufficiency, hepatic insufficiency; 7. Acute myocardial infarction or ischemic stroke within 6 months prior to enrollment; 8. Uncontrolled diabetes mellitus; 9. Active infection requiring systemic treatment (oral or intravenous) prior to enrollment (excluding viral hepatitis); 10. Peripheral neuropathy >= Grade 2; 11. Uncontrolled malignant pleural effusion, ascites, or pericardial effusion; 12. Gastrointestinal disease such as active gastric or duodenal ulcer, ulcerative colitis; or other conditions potentially causing gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation or fistula following surgical intervention; 13. Active tuberculosis, or antituberculosis therapy within 1 year prior to enrollment; 14. For HBsAg-positive and/or HBcAb-positive patients, HBV-DNA must be 1000 copies/mL; 16. Human Immunodeficiency Virus (HIV) antibody positive; 17. Received any live vaccine within 28 days prior to enrollment (e.g., vaccines for infectious diseases such as influenza or varicella); 18. History of allogeneic bone marrow transplantation or solid organ transplantation; 19. History of severe allergic reactions to monoclonal antibodies or other biologics; 20. Participation in other interventional clinical studies within 28 days prior to enrollment; 21. Presence of clinically significant underlying medical conditions judged by the investigator to potentially affect study drug administration or protocol compliance; 22. Other reasons deemed by the investigator to make the subject ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of Overall Response;progression free survival;overall survival;Treatment Emergent Adverse Events; | — |
Countries
China
Contacts
Public ContactYigui Chen
Fujian Provincial Tumor Hospital
Outcome results
None listed