Actively Recruiting
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-03-15
360
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
CONDITIONS
Official Title
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the Informed Consent Form and agreed to study procedures
- Age 18 years or older
- Histologically confirmed primary colon adenocarcinoma
- Radiographic evidence of resectable stage IIB-III colon cancer (cT4 or cN+ based on AJCC Stage VIII)
- Microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) status
- Able to undergo radical excision before neoadjuvant therapy
- At least one measurable lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 to 1
You will not qualify if you...
- Previous antitumor treatment for the current disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell co-stimulation or immune checkpoints, including adoptive cellular immunotherapy
- Concurrent participation in another interventional clinical trial (except observational or survival follow-up studies)
- Use of investigational drugs or devices within 4 weeks before starting the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jiayu Wen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here