Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2027

Conditions
Rectal Cancer
Interventions
DRUG

Sintilimab

6 cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) followed by long course chemoradiotherapy (50 Gy in 25 fractions) followed by surgery. Patients will receive sintilimab 3mg/kg every 2 weeks during chemoradiotherapy (2nd-6th cycle).

Trial Locations (1)

510000

RECRUITING

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou

Sponsors
All Listed Sponsors
collaborator

GeneCast Biotechnology Co., Ltd.

INDUSTRY

lead

Yanhong Deng

OTHER

NCT05450029 - Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter