The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 22, 2024

Primary Completion Date

December 30, 2024

Study Completion Date

December 30, 2027

Conditions
Rectal CancerRectal Cancer Stage IIRectal Cancer Stage III
Interventions
DRUG

Tislelizumab combined with chemotherapy

"Drug: Oxaliplatin Oxaliplatin 130mg/m2 for chemotherapy 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 report in BJC (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 report in BJC (2018) 118:1322-1328.~Drug: Anti-PD-1 Monoclonal Antibody 200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Anti-PD-1 Monoclonal Antibodies is relatively low. The PD-1 monoclonal antibody (Tislelizumab) dose adjustment was implemented according to the prescribing information.~Other Names:~Tislelizumab~Procedure: Colectomy The specific surgical approach, whether it be laparoscopic"

Trial Locations (1)

530021

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
lead

First Affiliated Hospital of Guangxi Medical University

OTHER