Clinical trial NCT06346093: Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
Official title: A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Gastric Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 1. 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 6 months
measure: Rate of Disease Control
timeFrame: up to 6 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
measure: Incidence of Adverse Events Related to Treatment
timeFrame: up to 6 months
measure: Change in the intestinal microbiome community
timeFrame: up to 6 months
measure: Quality of life based on the questionnaire
timeFrame: up to 2 years
measure: Change in the immunity
timeFrame: up to 6 months
Other outcomes:
measure: Marker of nutritional status
timeFrame: up to 2 years
measure: Marker of nutritional status
timeFrame: up to 2 years
measure: Marker of nutritional status
timeFrame: up to 2 years
measure: Body Weight
timeFrame: up to 2 years
measure: Appetite
timeFrame: up to 2 years
measure: Marker of nutritional status
timeFrame: up to 2 years
measure: Marker of nutritional status
timeFrame: up to 2 years
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References: