The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.
In this study, we explored the potential effectiveness of combining PD-1 monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide, with or without IBI305(bevacizumab), in MSS/pMMR unresectable locally advanced or metastatic colorectal cancer patients who failed standard chemotherapy and testified this new combination in preclinical models. Fourty-eight patients were randomized into two groups: the doublet group, who received sintilimab 200 mg every 3 weeks and chidamide 30 mg orally twice weekly, and the triplet group, who received sintilimab, chidamide, and bevacizumab 7.5 mg/kg every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
200mg IV on Day 1 Q3W
30mg PO BIW each 3-week cycle
7.5mg/kg IV on Day 1 Q3W
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
The progression-free survival (PFS) rates at 18 weeks
The proportion of patients without disease progression or death at the 18th week after initiation of the study treatment
Time frame: 24 months
Objective response rate (ORR)
The proportion of patients with a PR or CR
Time frame: 2 year
Progression-free survival (PFS);
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Time frame: 2 year
Overall Survival (OS);
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Time frame: 2 year
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Time frame: 2 year
Duration of response (DoR)
For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first
Time frame: 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.