Actively Recruiting
Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer
Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-02-17
36
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.
CONDITIONS
Official Title
Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily agree to participate and sign informed consent with good compliance
- Age between 18 and 75 years inclusive
- Histologically or cytologically confirmed metastatic colorectal cancer that is initially unresectable
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate blood counts without recent transfusion or hematopoietic growth factors
- Liver function within specified limits (bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN or ≤5×ULN with liver metastasis)
- Renal function with serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min
- Coagulation parameters within defined ranges (INR, PT, APTT ≤1.5×ULN)
- Thyroid function within normal limits or appropriately evaluated if abnormal
- Negative pregnancy test for women of reproductive age within 14 days before treatment
- Use of effective contraception during the study and for 3 months after last dose for reproductive-age women and male partners
You will not qualify if you...
- Received radiotherapy, surgery, chemotherapy, immunotherapy, molecular targeted therapy, or other investigational drugs within 4 weeks prior to treatment
- Active autoimmune disease requiring systemic therapy within the past 2 years
- Diagnosed with immune deficiency or received systemic steroid or immunosuppressive therapy within 7 days before first treatment
- Prior treatment with anti-vascular small-molecule targeted drugs such as fuquintinib
- Previous irinotecan-based chemotherapy
- Symptomatic brain or meningeal metastases
- RAS wild-type left-sided colon cancer
- Microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) metastatic colorectal cancer
- Severe infection or unexplained fever >38.5°C within 4 weeks before treatment
- Poorly controlled high blood pressure (≥140/90 mmHg)
- Recent significant bleeding or bleeding disorders within past 3 months
- Tumor invasion of major blood vessels posing bleeding risk
- Active heart disease including recent myocardial infarction or unstable angina
- History of other malignancies within 5 years except certain skin and cervical cancers
- Known allergy to study drugs or their components
- Active or uncontrolled severe infections, including HIV, active hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, China, 322000
Actively Recruiting
Research Team
D
Dezhi Li, MD&PhD
CONTACT
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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