Actively Recruiting
Cadonilimab with Bevacizumab and FOLFOX for First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm Multicenter Phase II Study
Led by Fudan University · Updated on 2024-01-23
53
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a combination treatment of Cadonilimab, bevacizumab, and FOLFOX chemotherapy for adults with advanced, unresectable metastatic colorectal cancer that is microsatellite stable (MSS) and has a RAS mutation. This Phase II, single-arm, open-label, multicenter trial aims to observe the one-year progression-free survival rate and other outcomes like overall response rate, perioperative safety, and long-term survival in this patient population. Participants will receive the combination of Cadonilimab, bevacizumab, and the FOLFOX chemotherapy regimen as their first-line treatment. This study includes only one experimental treatment group and focuses on evaluating the effects and safety of this combined therapy over time. During the trial, participants will be closely monitored with regular assessments to track their disease progression, treatment response, and any side effects. Researchers will measure outcomes such as the one-year progression-free survival rate, overall response rate, adverse event rates, progression-free survival, and overall survival over 24 months. The study will last up to two years, including safety follow-up and long-term observation.
CONDITIONS
Brief 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, any gender.
- Physical fitness score (ECOG) of 0 or 1.
- Expected survival of at least 3 months.
- Diagnosed with metastatic colorectal adenocarcinoma confirmed by histology or cytology.
- No prior systemic anti-tumor therapy and not suitable for radical surgery or local treatment.
- Genetic tests show proficient mismatch repair (pMMR) or microsatellite stable (MSS) status and RAS mutation.
- At least one measurable lesion according to RECIST v1.1, suitable for repeated measurements (excluding brain metastases and certain irradiated lesions).
You will not qualify if you...
- Known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- RAS wild-type status.
- Other malignant tumors within 3 years before enrollment, except cured local tumors.
- Participation in another clinical study unless observational or follow-up only.
- Recent systemic anti-tumor therapy within 3 weeks, local palliative treatment within 2 weeks, or certain immunomodulatory therapies within 2 weeks.
- Previous immunotherapy for tumors including checkpoint inhibitors or immune cell therapy.
- Active autoimmune diseases requiring systemic treatment within 2 years.
- History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- History of immunodeficiency or positive HIV antibody.
- Active tuberculosis or syphilis infection.
- History of allogeneic organ or stem cell transplantation.
- Previous or current 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive Cadonilimab in combination with bevacizumab and FOLFOX regimen as first-line treatment for advanced unresectable MSS-type, RAS-mutated metastatic colorectal cancer.
Regular visits as per treatment schedule
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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