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SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC

NCT07549399 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-04-24

No results posted yet for this study

Summary

To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.

Conditions

  • Rectal Adenocarcinoma
  • High-Risk Cancer
  • MSS

Interventions

RADIATION

Short-Course Radiotherapy

Patients undergo SCRT at a dose of 5Gy × 5 fractions

DRUG

PD-1 monoclonal antibody

Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.

DRUG

mFOLFOX6 regimen

Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.

DRUG

Cetuximab

Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.

DRUG

Bevacizumab

Patients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)

PROCEDURE

Surgical resection

Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jun Huang, PhD · Sun Yat-sen 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
2026-04-30
Primary Completion
2029-04-30
Completion
2029-04-30

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 NCT07549399 on ClinicalTrials.gov