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

July 27, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital
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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Zhansheng Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ECOG PS 0-1
  2. The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible
  3. RAS/BRAF wild type, pMMR/MSS status
  4. Patients of childbearing age need to take effective contraceptive measures.
  5. Voluntarily sign the informed consent form

Exclusion Criteria:

  1. dMMR/MSI-H type
  2. Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
  3. Active autoimmune diseases, inflammatory bowel disease;
  4. Active infection, immune deficiency, severe liver and kidney dysfunction;
  5. Severe intestinal obstruction, perforation or requiring emergency surgery;
  6. Pregnant or lactating women;
  7. Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.);
  8. Other circumstances where participation in clinical trials is not suitable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological Complete Response rate
Time Frame: After surgery, an average of 1-2 weeks
After surgery, an average of 1-2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: After the drug treatment is completed, an average of 1-2 weeks
After the drug treatment is completed, an average of 1-2 weeks
Major Pathological Response
Time Frame: After surgery, an average of 1-2 weeks
After surgery, an average of 1-2 weeks
R0 resection rate
Time Frame: After surgery, an average of 1-2 weeks
After surgery, an average of 1-2 weeks
sphincter-preserving rate
Time Frame: After surgery, an average of 1-2 weeks
After surgery, an average of 1-2 weeks
Safety（Adverse reactions）
Time Frame: During the treatment period, up to 3 months
During the treatment period, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LARC-BCAPOX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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