Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

Conditions

• Locally Advanced Colon Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Serplulimab — DRUG
  Serplulimab 300mg, d1, q3w
• short-term radiotherapy — RADIATION
  radiation: 25Gy/5Fx
• Oxaliplatin — DRUG
  130mg/m2 d1 q3w
• Capecitabine — DRUG
  1000mg/m2 d1-14 q3w

Study Details

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.

Key Dates

Start date

Mar 1, 2023

Status verified

Feb 2023

Primary completion

Dec 31, 2023

Completion

Dec 31, 2024

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: short-course radiotherapy and immunotherapy
  A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
• Active Comparator: chemotherapy
  A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.

Primary Outcome Measure

pCR [ Time Frame: The pCR rate will be evaluated after surgery, an average of 4 weeks ]