drugset / Trial / NCT06931808

Intestinal Microbiota Transplantation, Radiochemotherapy and Sintilimab in Localized Advanced Colon Cancer

NCT06931808

Phase 4 Enrolling by invitation 20 enrolled First Affiliated Hospital of Ningbo University
NaSingle-groupOpen-labelTreatment

Summary

The standard treatment for locally advanced rectal cancer is neoadjuvant chemoradiotherapy followed by total mesorectal excision. While Immune checkpoint inhibitors are promising in the treatment of various cancers, the combination of radiotherapy and immunotherapy still lacks high-level evidence-based medicine, and the efficacy is still limited in rectal cancer. Thus, we designed a study on the efficacy and safety of intestinal microbiota transplantation combined with synchronous radiochemotherapy and immune checkpoint inhibitor xindilimab neoadjuvant therapy for locally advanced rectal cancer.

Timeline

Start
2025-03-01
Primary completion
2026-03-01
Completion
2028-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject intestinal microbiota capsules Other / unclassified 30 unknown Oral

Indications