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To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR

NCT07738042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-07-30

No results posted yet for this study

Summary

To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)

Conditions

  • Locally Advanced Rectal Cancer (LARC)

Interventions

DRUG

Sintilimab

Sintilimab 200mg Q3W 2 cycles

DRUG

CAPOX (oxaliplatin/capecitabine)

CAPOX Q3W 2 cycles

RADIATION

Short-course radiotherapy

Short-course radiotherapy 25Gy/5 doses, completed within one week

BIOLOGICAL

Intestinal bacteria transplantation

Intestinal bacteria transplantation Q3W 2 cycles

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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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 NCT07738042 on ClinicalTrials.gov