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NOT YET RECRUITING
NCT07877597
PHASE3

Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy. In our previous small-sample phase II study, PD-1 inhibitor plus CAPOX chemotherapy combined with short-course radiotherapy yielded a marked improvement in the pCR rate compared with neoadjuvant CAPOX alone, though survival outcomes remain under follow-up. This prospective, multicentre, randomised, three-arm phase III study enrolls 480 patients with pMMR/MSS locally advanced high-risk colon cancer. Participants are randomised in a 2:2:1 ratio to three arms: short-course radiotherapy combined with chemotherapy and PD-1 inhibitor (25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab); chemotherapy plus PD-1 inhibitor (4 cycles of CAPOX combined with serplulimab); and chemotherapy alone (4 cycles of CAPOX). The primary endpoint is the 3-year event-free survival (EFS) rate. Secondary endpoints include the pCR rate, 5-year overall survival rate (5y OS), R0 resection rate, toxicity, surgical complications and quality of life.

Official title: A Prospective, Randomized, Multicenter, Phase III Clinical Study of Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS (TORCH-C2 Trial)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2026-10-15

Completion Date

2031-12-31

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

RADIATION

short-course radiotherapy

short-course radiotherapy with 25 Gy in 5 Fractions (25 Gy/5Fx)

DRUG

Serplulimab

A fixed dose of 300 mg is administered by intravenous infusion on Day 1 (D1), once every 3 weeks (Q3W).

DRUG

CapOx(Capecitabine+ Oxaliplatin)

Oxaliplatin (130 mg/m²) is administered by intravenous infusion on Day 1. Capecitabine 1000 mg/m² is given orally twice daily (bid) from Day 1 to Day 14, repeated every 3 weeks (Q3W).

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China