Neoadjuvant Cadonilimab Plus Chemotherapy Following Short-Course Radiotherapy in Locally Advanced Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 11, 2023

Primary Completion Date

October 31, 2024

Study Completion Date

January 31, 2025

Conditions
Locally Advanced Rectal Carcinoma
Interventions
DRUG

Cadonilimab Injection

Cadonilimab, an anti-CTLA-4/PD-1 bispecific antibody, at a dose of 6mg/kg is given in combination with chemotherapy every 2 weeks preoperatively and postoperatively.

RADIATION

Short-course radiotherapy

Preoperative short-course radiotherapy (5x5 Gy)

DRUG

Consolidation chemotherapy

Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2400 mg/m2 for 48 h) every 2 weeks for total 6 cycles preoperatively and postoperatively.

Trial Locations (1)

518020

Shenzhen People's Hospital, Shenzhen

All Listed Sponsors
collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

collaborator

The University of Hong Kong-Shenzhen Hospital

OTHER

lead

Shenzhen People's Hospital

OTHER