Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2030

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.

Trial Locations (1)

530021

The First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
collaborator

The First Affiliated Hospital of Xiamen University

OTHER

collaborator

The First Affiliated Hospital of University of South China

OTHER

lead

First Affiliated Hospital of Guangxi Medical University

OTHER