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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sintilimab
  • CAPOX (oxaliplatin/capecitabine)
  • Short-course radiotherapy
  • Intestinal bacteria transplantation

Treatment groups

46 Participants
are divided into 1 treatment group