FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage
NCT05279677 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-08-23
Summary
A single-arm, phase II study was designed to evaluate the efficacy and safety of fecal microbiota transplantation plus Sintilimab and Fruquintinib as the later line treatment in colorectal patients with advanced stages.
Conditions
- Colorectal Neoplasms Malignant
Interventions
- DRUG
-
Fecal microbiota transplantation plus Sintilimab and Fruquintinib
Microbiota capsules containing 1g gut microbiota, po d1-3 before anti-tumor treatment, total for 8 cycles. Sintilimab 200mg iv, q3w. Fruquintinib 5mg po d1-14, q3w.
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-12
- Primary Completion
- 2023-10-31
- Completion
- 2024-04-30
Countries
- China
Study Locations
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