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Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

NCT06462053 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-06-17

No results posted yet for this study

Summary

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Conditions

  • Early Low Rectal Cancer

Interventions

RADIATION

Short-course radiotherapy

Short-course radiotherapy: 25Gy/5Fx

DRUG

PD-1 antibody (Toripalimab)

Toripalimab 240mg d1 q3w

RADIATION

Long-course radiotherapy

Long-course radiation: 50Gy/25Fx

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

DRUG

Capecitabine

Xeloda

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, M.D, PH.D · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-04-01
Completion
2027-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462053 on ClinicalTrials.gov