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Not yet recruiting NCT07738042

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

No phase Interventional Locally Advanced Rectal Cancer (LARC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab, CAPOX (oxaliplatin/capecitabine), Short-course radiotherapy, Intestinal bacteria transplantation.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer (LARC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

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

Primary outcome measures

  • Pathological Complete Response rate [Time frame: After surgery, an average of 1-2 weeks]
Secondary outcome measures (5)
  • Objective response rate [Time frame: 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]
  • R0 resection rate [Time frame: After surgery, an average of 1-2 weeks]
  • sphincter-preserving rate [Time frame: After surgery, an average of 1-2 weeks]
  • Safety（Adverse reactions） [Time frame: During the treatment period, up to 3 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT07738042 · LARC-BCAPOX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗