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ACTIVE NOT RECRUITING
NCT06124378
PHASE2

Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

Sponsor: First Affiliated Hospital of Guangxi Medical University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-11-13

Completion Date

2026-11-30

Last Updated

2025-09-24

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Tislelizumab is relatively low. The Tislelizumab dose adjustment was implemented according to the prescribing information.

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

DRUG

Capecitabine

Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

PROCEDURE

Colectomy

The specific surgical approach is laparoscopic. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.

Locations (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China