NCT04304209View on ClinicalTrials.gov

Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

October 18, 2026

Study Completion Date

October 18, 2026

Conditions
Colorectal Cancer Stage IIColorectal Cancer Stage III
Interventions
DRUG

Oxaliplatin

130mg/m2, d1 q3w, in Capeox regimen (100mg/m2 when used cocurrently with radiotherapy), intravenous infusion

DRUG

Capecitabine

1000mg/m2, bid, qd1-14, q3w, in Capeox regimen, oral administration

DRUG

Sintilimab

200mg, d1 q3w, intravenous infusion

RADIATION

radiotherapy

neoadjuvant radiotherapy with 50Gy to GTV, 45Gy to CTV in 25 fractions.

PROCEDURE

total mesorectal excision

total mesorectal excision after neoadjuvant treatment

OTHER

Watch and wait

Watch and wait for cCR patients after neoadjuvant treatment

Trial Locations (1)

510060

Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER