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NOT YET RECRUITING
NCT07738042
NA

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

View on ClinicalTrials.gov

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

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

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China