Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
ConditionAdvanced Gastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD1/PDL1 therapy in the advanced gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation Capsules
Procedure/SurgeryFMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy
Placebo
Procedure/SurgeryMainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Placebo capsulesPlacebo comparator 1 intervention
Group B: FMT capsulesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
ORR is defined as the percentage of subjects who had a complete response (CR) or partial response (PR), as defined by ir-RECIST v1.1, and is based on the best response obtained.
Time frame
up to 6 months2
Rate of Disease Control
Rate of Disease Control is defined as the percentage of subjects who had a complete response (CR), partial response (PR), or stable disease (SD), as defined by ir-RECIST v1.1.
Time frame
up to 6 monthsSecondary outcomes
1
Progression-free Survival (PFS)
The median length of time from initiation of study drug(s) disease progression as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame
up to 2 years2
Overall Survival (OS)
The length of time (in days) from study intervention that participants remain alive.
Time frame
up to 2 years3
Incidence of Adverse Events Related to Treatment
All adverse events and their relationships to study drugs and procedures will be recorded，to assess overall safety, feasibility and tolerability of treatment.
Time frame
up to 6 months4
Change in the intestinal microbiome community
Mean change from baseline of bacterial species compared with 6 months post fecal microbiota transplantation (FMT).
Time frame
up to 6 monthsOther outcomes
1
Marker of nutritional status
Hemoglobin is a measure of the nutritional status and are seen as markers for the catabolic state of cachectic cancer patients.
Time frame
up to 2 years2
Marker of nutritional status
Creatinin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.
Time frame
up to 2 years3
Marker of nutritional status
Albumin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.
Time frame
up to 2 years4
Body Weight
Body Weight Change. (kilograms)
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov