Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

September 1, 2024

Study Completion Date

September 1, 2027

Conditions
Colorectal Cancer
Interventions
DRUG

Serplulimab + FOLFOXIRI

Starting from day 0, the patient will receive 8 cycles of FOLFOXIRI regimen at specific intervals. The FOLFOXIRI regimen includes irinotecan 165mg/m2, oxaliplatin 85mg/m2, calcium folinate 200mg/m2 on day 1, followed by continuous intravenous infusion of 5-FU 2400mg/m2/day for 46 hours. This regimen is repeated every 14 days.During radiotherapy (Monday to Friday), the patient will receive capecitabine 1650mg/m2/day orally twice daily. Serplulimab immunotherapy will be administered every 2 weeks during the FOLFOXIRI neoadjuvant chemotherapy period. Serplulimab will be given on the first day and the 14th day of radiotherapy, dissolved in 100ml normal saline and administered intravenously over 30-60 minutes at a dose of 200mg.

RADIATION

Radiation therapy

Radiation therapy

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT06099951 - Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy | Biotech Hunter | Biotech Hunter