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Role of Gut Microbiota in Neoadjuvant Radioimmunotherapy for MSS, Locally Advanced Rectal Cancer

NCT06898359 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2025-03-27

No results posted yet for this study

Summary

This research investigates the role of the gut microbe in patients receiving radioimmunotherapy with locally advanced microsatellite-stable (MSS) rectal cancer. Given the limitations of current treatment strategies in achieving optimal clinical outcomes, this prospective, single-center, phase II clinical trial aims to improve pathological complete response (pCR) rates. The primary endpoint is pCR, with secondary endpoints including disease-free survival (DFS) and the incidence of treatment-related adverse events. This study seeks to provide insights into a novel treatment paradigm for MSS locally advanced rectal cancer, potentially offering improved therapeutic options for this patient population.

Conditions

Interventions

RADIATION

Radioimmunotherapy

SCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles)

Sponsors & Collaborators

  • Yanhong Deng

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2023-07-03
Completion
2023-08-28

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 NCT06898359 on ClinicalTrials.gov