At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
FMT capsulebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigator-initiated Trial of Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti-PD-1 in Patients with PD-(L)1 Resistant Digestive System Cancers
In Brief
A Phase 1 clinical trial evaluating FMT capsule for Gastrointestinal System Cancer. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal System Cancer
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartDec 2019
Primary CompletionFeb 2023
Study CompletionJan 2024
TodayJul 2026
First PostedOct 17, 2019
Enrollment StartDec 5, 2019
Primary CompletionFeb 1, 2023
Study CompletionJan 29, 2024
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 6.7 years ago
Interventions
FMT capsulebiological
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.