Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer

NCT06346093 | Recruiting

• 1 other identifier: CHEC2024-089
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Objective 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.

  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.

  up to 6 months

Secondary Outcomes (6)

• Progression-free Survival (PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

• Incidence of Adverse Events Related to Treatment

  up to 6 months

• Change in the intestinal microbiome community

  up to 6 months

• Quality of life based on the questionnaire

  up to 2 years

Other Outcomes (7)

• Marker of nutritional status

  up to 2 years

• Marker of nutritional status

  up to 2 years

• Marker of nutritional status

  up to 2 years

Study Arms (2)

Placebo capsules

PLACEBO COMPARATOR

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.

Procedure: Placebo

FMT capsules

EXPERIMENTAL

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.

Procedure: Fecal Microbiota Transplantation Capsules

Interventions

Fecal Microbiota Transplantation Capsules PROCEDURE

FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy

Also known as: FMT Capsules

FMT capsules

Placebo PROCEDURE

Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules

Placebo capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Xiangyu Kong, associate professor

CONTACT

13564644397; xiangyukong185@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 3, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CN (1)