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TIME in Immunotherapy Combined With nCRT for Rectal Cancer — TIMENT-R  

Locally Advanced Rectal Cancer Clinical Trial

Official title:
The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer

Clinical Trial Summary

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Clinical Trial Description

Objectives: 1. To clarify the efficacy and safety of combined therapy for locally advanced rectal cancer (LARC) patients and verify the efficacy and safety of neoadjuvant immunotherapy for dMMR/MSI-H LARC patients. 2. To clarify the effect of nCRT on TIME for rectal cancer, and the further effect of adding Immunotherapy. 3. To verify the feasibility of predicting the efficacy of combined therapy by the infiltration level of CD8+ PD1+ TILs in tumor tissue before treatment in pMMR/MSS LARC patients and explore the comprehensive prediction index of the efficacy of combined therapy for LARC patients. 4. To clarify the potential mechanism of immune response or immune escape to neoadjuvant immunotherapy for LARC patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05507112
Study type Interventional
Source Peking Union Medical College Hospital
Contact Jiaolin Zhou, Ph.D
Phone +86-13910136704
Email conniezhjl@163.com
Status Not yet recruiting
Phase Phase 2
Start date September 20, 2022
Completion date December 1, 2029
View Details
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