Actively Recruiting
XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-08-01
52
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 score of 0 or 1
- Ability to swallow oral medications
- At least one measurable lesion by RECIST v1.1
- No anti-tumor treatment after recurrence and metastasis
- Completed neoadjuvant or adjuvant chemotherapy with fluorouracil drugs for 6 months or more; if oxaliplatin was used, completed for 12 months or more
- Adequate organ function with specified blood counts, liver and kidney function, and heart function
- Expected survival of 3 months or more
- Fully understand and voluntarily participate with signed informed consent
- Women with reproductive potential and men must use effective contraception until six months after last treatment
You will not qualify if you...
- Previous 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-positive or other immunodeficiency diseases
- Active hepatitis B or C infections
- Autoimmune diseases requiring immunosuppressant treatment, except certain controlled conditions
- Recent systemic hormone or immunosuppressive therapy exceeding specified limits
- History of organ transplantation
- Uncontrolled central nervous system metastasis or disease
- Major surgery or trauma within 1 month or planned during study
- Other malignant tumors except certain cured skin or cervical cancers
- Active and refractory infections
- Significant cardiovascular diseases or events in past 6 months
- Conditions causing coagulation disorders
- Severe gastrointestinal conditions like obstruction or bleeding
- Severe unhealed wounds or fractures
- Serious medical or psychiatric conditions affecting study participation
- Pregnant or breastfeeding women
- No therapeutic anticoagulant or antiplatelet drugs except low-dose aspirin
- Severe allergic reactions to study drugs
- Refusal to use alternative therapies if receiving RANKL inhibitors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lin Yang
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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