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Bevacizumab

Antineoplastic Agents, Immunological

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Every 3 weeks, patients received sintilimab 200 mg and IBI305(bevacizumab) 7.5 mg/kg on day one and chidamide 30 mg orally twice weekly.

Every 3 weeks, patients received sintilimab 200 mg on day one and chidamide 30 mg orally twice weekly.

Sintilimab

Chidamide

IBI305

Ruihua Xu, MD, PhD

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.

Subjects will be randomized in approximately a 1:1 ratio to receive sintilimab and chidamide with or without IBI305.

Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

A Randomized Phase 2 Clinical Trial Evaluating Sintilimab and Chidamide in Combination With or Without IBI305 in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

The proportion of patients without disease progression or death at the 18th week after initiation of the study treatment

The proportion of patients with a PR or CR

The time from enrollment until tumor progression or death from any cause, whichever occurred first

The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date

The proportion of patients with a PR, CR, or SD

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma	NCT04724239	Advanced Micros... Metastatic Micr...	Sintilimab Chidamide IBI305	18 Years - 75 Years	Sun Yat-sen University
Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma	NCT04724239	Advanced Micros... Metastatic Micr...	Sintilimab Chidamide IBI305	18 Years - 75 Years	Sun Yat-sen University
Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma	NCT04724239	Advanced Micros... Metastatic Micr...	Sintilimab Chidamide IBI305	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for advanced microsatellite stable colorectal cancer