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Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)

NCT06923345 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-18

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer.

The main questions it aims to answer are:

Does this TNT approach improve complete response (CR) rates?

How does selective reduction of clinical target volume (CTV) to S2/S3 level compare with conventional CTV irradiation in terms of efficacy and safety?

Researchers will compare a selective CTV reduction group and a conventional CTV irradiation group to assess differences in treatment outcomes, including complete response, tumor regression grading (TRG), organ preservation, R0 resection rates, and long-term survival.

Participants will:

Receive long-course chemoradiotherapy with either conventional or reduced CTV irradiation.

Undergo sequential chemotherapy.

Receive PD-1 inhibitor treatment.

Be monitored for safety, tumor regression, and long-term survival outcomes.

Conditions

  • Rectal Cancer
  • Neoadjuvant Therapies
  • Immune Checkpoint Therapy
  • Radiotherapy

Interventions

COMBINATION_PRODUCT

Reduced CTV

Long-course radiotherapy with selective CTV reduction (lower to S2/S3 level) + CAPOX + PD-1 inhibitor. After treatment, patients will undergo TME surgery or a watch-and-wait approach, depending on response.

COMBINATION_PRODUCT

Conventional CTV

Long-course radiotherapy with conventional CTV irradiation + CAPOX + PD-1 inhibitor. After treatment, patients will undergo TME surgery or a watch-and-wait approach, depending on response.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen 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
2025-03-31
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06923345 on ClinicalTrials.gov