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ACTIVE NOT RECRUITING
NCT04304209
PHASE2

Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

In this study, participants with locally advanced rectal cancer patients will be treated according to MMR/MSI status. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, dMMR or MSI-H patients will receive 4 cycles of neoadjuvant Pd1 antibody Sintilimab,followed by one of the following treatments: (1) surgery and adjuvant treatment, (2)another 4 cycles of sintilimab, followed by radical surgery or observation (only for cCR) . For Cohort B, pMMR/MSS/MSI-L patients will be randomized to receive neoadjuvant chemoradiotherapy ± four cycles of Pd1 antibody Sintilimab,followed by one of the following treatments: (1) curative surgery and four cycles of adjuvant chemotherapy;(2)four cycles of chemotherapy then observation (only cCR after neoadjuvant therapy)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2019-10-28

Completion Date

2026-10-18

Last Updated

2023-02-01

Healthy Volunteers

No

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

Locations (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China