Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 13, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

November 30, 2026

Conditions
Colonic NeoplasmsNeoadjuvant TherapyImmune Checkpoint Inhibitors
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.

Trial Locations (1)

530021

The First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
lead

First Affiliated Hospital of Guangxi Medical University

OTHER

NCT06124378 - Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer | Biotech Hunter | Biotech Hunter