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NCT07738042

Overview

NCT ID: NCT07738042
Lead Sponsor: Tianjin Medical University Cancer Institute and HospitalOTHER
Official Title: 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
Brief 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: Sintilimab

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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