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Clinical Trials in China / NCT07738042
Starting soon Not applicable

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 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Not applicable
Started
2026-07-31
Last updated
2026-07-30

Condition(s) studied

Locally Advanced Rectal Cancer (LARC)

Investigational drug(s) / intervention(s)

SintilimabCAPOX (oxaliplatin/capecitabine)Short-course radiotherapyIntestinal bacteria transplantation

Sintilimab: Sintilimab 200mg Q3W 2 cycles

CAPOX (oxaliplatin/capecitabine): CAPOX Q3W 2 cycles

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

Intestinal bacteria transplantation: Intestinal bacteria transplantation Q3W 2 cycles

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin China

More Tianjin Medical University Cancer Institute and Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07738042 on ClinicalTrials.gov ↗ ← All trials in China