20
Participants
Start Date
March 1, 2025
Primary Completion Date
March 1, 2026
Study Completion Date
August 1, 2028
Sintilimab plus Chemotherapy
All patients received standard long-term radiation therapy (LCRT) (50.0Gy/25f) and concurrent chemotherapy with capecitabine (825 mg/m2, bid, po) (Phase 1); Xelox scheme (Oxaliplatin 130 mg/m2, ivgtt ,d1; Capecitabine 1000 mg/m2, bid,d1-14) (Phase 2); . During the radiotherapy and chemotherapy period, they also received two cycles of immunotherapy with Sintilimab (200mg, ivgtt, d1, q3w).
Intestinal microbiota capsules
During Phase 1, intestinal microbiota transplantation treatment, oral intestinal microbiota capsules are used for transplantation treatment, with a dose of 30 capsules/day (about 1U sediment microbiota, containing about 1 × 1013 bacteria). Transplantation is carried out continuously for 3 days starting from each week, for a total of 3 courses of treatment.
Standard Long Course Radiotherapy
50.0Gy/25f
Total mesorectal excision
6-8 weeks after the end of the first phase and combined with 5 cycles of Xelox regimen adjuvant chemotherapy.
First Affiliated Hospital of Ningbo University, Ningbo
First Affiliated Hospital of Ningbo University
NETWORK