A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer

Changhai Hospital1 site in 1 country124 target enrollmentApril 2, 2024

ConditionsAdvanced Gastric Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Gastric Cancer
Sponsor: Changhai Hospital
Enrollment: 124
Locations: 1
Primary Endpoint: Rate of Disease Control
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2, 2024

End Date

June 30, 2030

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changhai Hospital

Responsible Party

Principal Investigator

Xiangyu Kong

Principle Investigator

Changhai Hospital

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate in this study and provide written informed consent. Age ≥ 18 years , male or female. Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma.
•Able and willing to provide tumor tissue. At least one measurable extracranial target lesion according to iRECIST. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
•Life expectancy ≥3 months.

Exclusion Criteria

•Presence of absolute contra-indications to FMT administration:Toxic megacolon;Inflammatory bowel disease;Anatomic contra-indications to colonoscopy;Colectomy Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.
•Currently under any form of systemic antibiotics. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (\> 10 mg prednisone daily or equivalent).
•Severe anaphylactic reaction to any food (food allergies). Had a severe hypersensitivity reaction to propofol. Has serious concomitant illnesses. The eligibility can be granted by the treating investigator on individual bases.
•Has HIV infection or AIDS-related illness. Has active infection of HAV, HBV or HCV. Patients with a history of Hepatitis B/C infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with Principal Investigator.
•Patient has received a live vaccine within 4 weeks prior to the first dose of treatment. Seasonal influenza vaccines or COVID-19 vaccines for injection are generally inactivated virus vaccines and are allowed.
•Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
•Females who are pregnant or breastfeeding. Active central nervous system (CNS) metastases and/or leptomeningeal involvement

Outcomes

Primary Outcomes

Rate of Disease Control

Time Frame: up to 6 months

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.

Objective response rate (ORR)

Time Frame: up to 6 months

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.