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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
Sponsor: Tianjin Medical University Cancer Institute and Hospital
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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2026-07-31
Completion Date
2030-12-31
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China