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SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer

NCT07551479 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2026-04-24

No results posted yet for this study

Summary

In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \[pCR\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.

Conditions

  • Locally Advanced Rectal Cancer (LARC)
  • MSS (Microsatellite Stable)

Interventions

DRUG

PD-1 inhibitor

Serplulimab 300mg d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid d1-14 q3w

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 d1 q3w

RADIATION

short-course radiaotherapy

short-course radiaotherapy (25Gy/5Fx)

RADIATION

long-course chemoradiaothearpy

long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine 825mg/m2 bid d1-5 qw)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

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
2026-05-01
Primary Completion
2032-12-31
Completion
2035-12-31

Countries

  • China

Study Locations

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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 NCT07551479 on ClinicalTrials.gov