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Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1

NCT04130763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-24

No results posted yet for this study

Summary

To determine whether the fecal microbiota transplant (FMT) capsule can help reverse the resistance of anti-PD-(L)1 treatment in Gastrointestinal (GI) cancer patients.

Conditions

  • Gastrointestinal System Cancer

Interventions

BIOLOGICAL

FMT capsule

FMT capsules administration starts in the first week of enrollment. Capsules are taken for three consecutive days in the first week. From week 2, anti-PD-1 therapy will be administrated in combination with the maintenance dose of FMT treatment once every two weeks for up to 6 times.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, MD · Peking University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2023-02-01
Completion
2024-01-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130763 on ClinicalTrials.gov