Actively Recruiting
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer
Led by Fudan University · Updated on 2024-01-23
53
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The dual immunotherapy regimen significantly outperformed previous chemotherapy or immunomonotherapy for MSS type advanced CRC in two key efficacy indicators, ORR and PFS. Researchers have also conducted in-depth analysis of patient transcriptomics, immune microenvironment characteristics, and other related information, which is expected to guide more accurate immune combination therapy for CRC in the future. Our team plans to conduct a multicenter, prospective, single arm clinical trial in patients with RAS mutant MSS unresectable metastatic colorectal cancer, with a focus on observing the 1-year progression free survival rate of the combination of two chemotherapy drugs, bevacizumab and Cadonilimab, as well as ORR, perioperative safety, and long-term survival.
CONDITIONS
Official Title
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Age between 18 and 75 years old, male or female.
- Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0 or 1.
- Expected survival time of at least 3 months.
- Diagnosis of metastatic colorectal adenocarcinoma confirmed by histology or cytology.
- No prior systemic anti-tumor therapy and not suitable for radical surgery or local treatment.
- Genetic testing confirming pMMR or MSS status and RAS mutation.
- At least one measurable lesion suitable for repeat and accurate measurement according to RECIST v1.1 (brain metastases cannot be target lesions; previously radiated lesions not preferred unless criteria met).
You will not qualify if you...
- Known high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR).
- RAS wild-type genotype.
- Other malignant tumors within 3 years before enrollment, except cured local tumors.
- Participation in another clinical interventional study, except observational or follow-up studies.
- Received systemic anti-tumor therapy within 3 weeks before first dose.
- Received palliative local treatment on non-target lesions within 2 weeks before first dose.
- Received non-specific immunomodulatory therapy within 2 weeks before first dose.
- Used Chinese herbal medicines with anti-tumor effects within 1 week before first dose.
- Prior tumor immunotherapy including immune checkpoint inhibitors or immune cell therapy.
- Active autoimmune diseases requiring systemic treatment in the past 2 years.
- History of active or previous inflammatory bowel disease.
- History of immunodeficiency, positive HIV test, or long-term use of immunosuppressants.
- Active pulmonary tuberculosis or syphilis infection.
- History of organ or hematopoietic stem cell transplantation.
- Current or prior non-infectious pneumonia or interstitial lung disease requiring systemic glucocorticoids.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan hosptial, Fudan University
Shanghai, China, 200032
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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