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

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.

Conditions

• Locally Advanced Rectal Carcinoma

Interventions

DRUG

Tislelizumab

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

Sponsors & Collaborators

• Beijing Chao Yang Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Zhongnan Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Xijing Hospital of Airforce Medical University

  collaborator UNKNOWN

• Tangdu Hospital-Air Force Medical University

  collaborator UNKNOWN

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Daping Hospital, the Third Military Medical University

  collaborator UNKNOWN

• Tianjin Union Medical Center

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• The Affiliated Tumour Hospital of China Academy of Medical Science

  collaborator UNKNOWN

• Rocket Force Characteristic Medical Center

  collaborator UNKNOWN

• Tianjin Medical University General Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Naval Medical University

  collaborator UNKNOWN

• West China Hospital

  collaborator OTHER

• Southern Medical University - Southern Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Zhejiang Tumor Hospital

  collaborator OTHER

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• Beijing Hospital of the Ministry of Health

  collaborator UNKNOWN

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Taiwan Hexin Cancer Center Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Beijing Friendship Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-16

Primary Completion

2026-12-01

Completion

2026-12-01

Countries

• China

Study Locations