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Trial Title:
Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
NCT ID:
NCT06346093
Condition:
Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Fecal Microbiota Transplantation Capsules
Description:
FMT Capsules in Combination with Chemotherapy and Anti-PD-L1 Therapy
Arm group label:
FMT capsules
Other name:
FMT Capsules
Intervention type:
Procedure
Intervention name:
Placebo
Description:
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as
FMT capsules
Arm group label:
Placebo capsules
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-PD-L1 therapy in the advanced gastric cancer.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangyu Kong, Associate Professor
Phone:
13564644397
Email:
xiangyukong185@hotmail.com
Start date:
April 2, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06346093
