Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
NCT ID: NCT06346093
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2024-04-02
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo capsules
Placebo capsules will be administered orally three days and then every three weeks for 24 weeks. SOX and anti-PD1/PD-L1 will be intravenously infused every three weeks for 24 weeks.
Placebo
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules
FMT capsules
FMT capsules will be administered orally three days and then every three weeks for 24 weeks. SOX and anti-PD1/PD-L1 will be intravenously infused every three weeks for 24 weeks.
Fecal Microbiota Transplantation Capsules
FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy
Interventions
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Fecal Microbiota Transplantation Capsules
FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy
Placebo
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Xiangyu Kong
Principle Investigator
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2024-089
Identifier Type: -
Identifier Source: org_study_id
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