Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC

PHASE3RecruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

Conditions
Metastatic Microsatellite-stable Colorectal Cancer
Interventions
DRUG

Experimental drug

The treatment option for the chidamide + sintilimab + bevacizumab is 200 mg of sintilimab IV Drip Q3W, 30 mg of chidamide PO BIW, and bevacizumab 7.5 mg/kg IV Drip Q3W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.

DRUG

Control Rx

The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400 mg/m2 IV Q2W or calcium levofolinate 200 mg/m2 IV Drip Q2W, 5-fluorouracil 400 mg/m2 IV +2400 mg/m2 CIV (infusion 46-48 hr) Q2W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.

Trial Locations (12)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

Unknown

NOT_YET_RECRUITING

Anhui Provincial Cancer Hospital, Hefei

NOT_YET_RECRUITING

The First People's Hospital of Foshan, Foshan

NOT_YET_RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou

NOT_YET_RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

NOT_YET_RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

NOT_YET_RECRUITING

The Second Affiliated Hospital of Kunming Medical University, Kunming

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER