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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective 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 months
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 months
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 years
Overall Survival (OS)
The length of time (in days) from study intervention that participants remain alive.
Time frame: up to 2 years
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 months
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 months
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Quality of life based on the questionnaire
The EORTC QLQ-STO22/EORTC QLQ-C30 questionnaire will be used to assess the quality of life of the participants.
Time frame: up to 2 years
Change in the immunity
Mean change from baseline of immune cells compared with 6 months post fecal microbiota transplantation (FMT).
Time frame: up to 6 months