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

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

August 1, 2028

Conditions
Localized Advanced Rectal Adenocarcinoma
Interventions
DRUG

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).

DRUG

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.

RADIATION

Standard Long Course Radiotherapy

50.0Gy/25f

PROCEDURE

Total mesorectal excision

6-8 weeks after the end of the first phase and combined with 5 cycles of Xelox regimen adjuvant chemotherapy.

Trial Locations (1)

315000

First Affiliated Hospital of Ningbo University, Ningbo

All Listed Sponsors
lead

First Affiliated Hospital of Ningbo University

NETWORK