Spots Global Cancer Trial Database for TIME in Immunotherapy Combined With nCRT for Rectal Cancer

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Trial Identification

Brief Title: TIME in Immunotherapy Combined With nCRT for Rectal Cancer

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

Study ID: NCT05507112

Conditions

Locally Advanced Rectal Cancer

Interventions

PD-1 inhibitor

Capecitabine

Long-course radiation therapy

Study Description

Brief 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.

Detailed 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.