Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

Colonic Neoplasms Clinical Trial

Official title: Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer: A Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study

Status Recruiting

Clinical Trial Summary

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.

Clinical Trial Description

The standard treatment for locally advanced colon cancer is complete mesocolic excision (CME) followed by adjuvant chemotherapy. The MOSAIC and 16968 studies have shown that about 30% of patients experience recurrence and metastasis within 6-7 years after surgery. Neoadjuvant chemotherapy may improve the prognosis of colon cancer patients. The significant tumor remission after neoadjuvant therapy probably indicates a better long-term survival for patients. The OPTICAL and Fluoropyrimidine Oxaliplatin and Targeted Receptor Pre-Operative Therapy (FoxTROT) studies have shown that approximately 35% of patients are resistant to oxaliplatin-containing neoadjuvant chemotherapy, with a pathological complete response (pCR) rate of less than 10% and uncertain survival improvement. Moreover, previous study shown that immunotherapy has unsatisfied efficacy for microsatellite stable (MSS) colon cancer. Therefore, it is necessary to explore more effective neoadjuvant treatment strategy for tumor therapy.

Immunogenic cell death will be enhanced by oxaliplatin-induced immunogenicity and combined with anti-programmed cell death 1 (PD-1) monoclonal antibodies for neoadjuvant therapy. The study will conduct 2 or 4 cycles of Tislelizumab with Oxaliplatin and Capecitabine, followed by CME surgery. The study's primary endpoint is the proportion of pCR in the pathological specimens of surgically resected tumors. ;

Related Conditions & MeSH terms

• Colonic Neoplasms
• Immune Checkpoint Inhibitors
• Neoadjuvant Therapy

• NCT number: NCT06124378
• Study type: Interventional
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: Minglin Lin
• Phone: +86-771-5356529
• Email: linminglin@sr.gxmu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2023
• Completion date: November 30, 2026