Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06312982

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

Locally Advanced Rectal Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06312982
Study type Interventional
Source Beijing Friendship Hospital
Contact Zhongtao Zhang, MD
Phone +86 13801060364
Email Zhangzht@ccmu.edu.cn
Status Recruiting
Phase Phase 2/Phase 3
Start date February 20, 2024
Completion date December 2026
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05920928 - Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer N/A
Completed NCT06314737 - Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Recruiting NCT05524012 - Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
Recruiting NCT05601505 - Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05876026 - MRI T1 Relaxation Time in Rectal Cancer
Completed NCT05622357 - Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer Phase 2
Terminated NCT04406857 - Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer Phase 1
Not yet recruiting NCT06276686 - Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer N/A
Not yet recruiting NCT06292975 - Exercise for Improving Radiotherapy Efficacy in Rectal Cancer N/A
Recruiting NCT05591534 - Endorectal Brachytherapy for Rectal Cancer Phase 2
Recruiting NCT05722288 - Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers Phase 2
Not yet recruiting NCT05645094 - Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer
Active, not recruiting NCT06314750 - Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer
Recruiting NCT05731726 - Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer Phase 2
Recruiting NCT04703101 - Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer Phase 1
Recruiting NCT05610163 - Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation Phase 2
Recruiting NCT05245786 - An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer Early Phase 1
Terminated NCT03280277 - Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer Early Phase 1
Recruiting NCT05772923 - Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision N/A
Recruiting NCT05792735 - Neoadjuvant Cadonilimab Plus Chemotherapy Following Short-Course Radiotherapy in Locally Advanced Rectal Cancer Phase 2