Actively Recruiting
XELOX and Bevacizumab Combined With Tislelizumab for First-Line Treatment of MSSpMMR RAS-mutated Metastatic Colorectal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-08-01
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of XELOX oxaliplatin and capecitabine, bevacizumab, and tislelizumab for treating patients with MSSpMMR-type RAS-mutated metastatic colorectal adenocarcinoma. This phase II study aims to assess the safety and effectiveness of this regimen, which is designed to turn RAS-mutated colorectal cancer into a hot tumor to improve response through combined chemotherapy, anti-vascular therapy, and immunotherapy. Participants receive treatment in cycles every three weeks. Each cycle includes intravenous tislelizumab 200 mg, bevacizumab 7.5 mgkg, and oxaliplatin 130 mgm2 on day 1, plus oral capecitabine 1000 mgm2 twice daily for 14 days. After eight cycles, patients enter maintenance therapy with capecitabine, bevacizumab, and tislelizumab. Patients are re-evaluated every two cycles to monitor progress. During the study, participants undergo assessments of tumor response, safety, and disease progression over two years, including measuring the objective response rate. Additional outcomes include duration of response, disease control rate, progression-free survival, overall survival, and treatment-related side effects. The study is designed to last up to five years for some outcomes, with ongoing monitoring for safety and effectiveness.
CONDITIONS
Brief Title
XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma
- ECOG performance status of 0 or 1
- Ability to swallow oral medications
- At least one measurable lesion according to RECIST v1.1
- No anti-tumor treatment after recurrence or metastasis
- Completed neoadjuvant or adjuvant fluorouracil-based chemotherapy for at least 6 months; if oxaliplatin used, regimen completed for at least 12 months
- Adequate organ function with specific blood counts and liver, kidney, heart function within defined limits
- Expected survival of 3 months or longer
- Voluntary informed consent
- Use of effective contraception for women with reproductive potential and men until 6 months after last treatment
You will not qualify if you...
- Prior treatment with bevacizumab, anti-CTLA4, anti-PD-1/PD-L1 antibodies, or pathway-targeted drugs
- Radiotherapy within 4 weeks before evaluation
- Symptomatic peripheral neuropathy above grade 2
- Live vaccine or systemic immune stimulant within 1 month
- HIV infection or other immunodeficiency diseases
- Active hepatitis B or C infection except certain controlled cases
- Autoimmune diseases requiring immunosuppressants except type 1 diabetes, hypothyroidism on hormone therapy, or some skin diseases
- Systemic hormone therapy exceeding 10 mg prednisone equivalent daily within 7 days
- History of organ transplantation
- Uncontrolled central nervous system metastases or diseases
- Major surgery or biopsy within 1 month or planned during study
- Other active malignant tumors except certain skin or cervical cancers treated over 1 year ago
- Active refractory infections
- Significant cardiovascular diseases or recent thromboembolic events
- Conditions causing coagulation disorders
- Gastrointestinal disorders like dysphagia, active ulcers, obstruction, bleeding, or inflammatory diseases
- Severe wounds or fractures
- Serious acute or chronic medical or psychiatric conditions affecting study participation
- Pregnancy or lactation
- No therapeutic anticoagulant or antiplatelet drugs except low-dose aspirin
- Severe allergic reactions to study drugs
- Reluctance to use alternative therapies like bisphosphonates if receiving RANKL inhibitors
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