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RECRUITING
NCT06312982
PHASE2/PHASE3

A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer. The main questions it aims to answer are: To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX(Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO)regimen. Two CAOPX regimens were treated one week apart.

Official title: A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2024-03-16

Completion Date

2026-12-01

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.

Locations (2)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China