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Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

NCT04304209 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-02-01

No results posted yet for this study

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)

Conditions

  • Colorectal Cancer Stage II
  • Colorectal 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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2026-10-18
Completion
2026-10-18

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304209 on ClinicalTrials.gov