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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
Conditions: Locally Advanced Rectal Cancer (LARC)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Location: Tianjin Medical University Cancer Institute & Hospital Tianjin
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)
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07738042). StuddyBuddy aggregates publicly available trial information.