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NCT Number: NCT06346093

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Xiangyu Kong, Associate Professor

CONTACT

[email protected]

13564644397

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplantation Capsules

Procedure

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

Other names: FMT Capsules

Placebo

Procedure

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

Primary outcomes

  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.

  2. 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.

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: up to 2 years

    The median length of time from initiation of study drug(s) disease progression as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

  2. Overall Survival (OS)

    Time frame: up to 2 years

    The length of time (in days) from study intervention that participants remain alive.

  3. Incidence of Adverse Events Related to Treatment

    Time frame: up to 6 months

    All adverse events and their relationships to study drugs and procedures will be recorded,to assess overall safety, feasibility and tolerability of treatment.

  4. Change in the intestinal microbiome community

    Time frame: up to 6 months

    Mean change from baseline of bacterial species compared with 6 months post fecal microbiota transplantation (FMT).

  5. Quality of life based on the questionnaire

    Time frame: up to 2 years

    The EORTC QLQ-STO22/EORTC QLQ-C30 questionnaire will be used to assess the quality of life of the participants.

  6. Change in the immunity

    Time frame: up to 6 months

    Mean change from baseline of immune cells compared with 6 months post fecal microbiota transplantation (FMT).

Other outcomes

  1. Marker of nutritional status

    Time frame: up to 2 years

    Hemoglobin is a measure of the nutritional status and are seen as markers for the catabolic state of cachectic cancer patients.

  2. Marker of nutritional status

    Time frame: up to 2 years

    Creatinin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.

  3. Marker of nutritional status

    Time frame: up to 2 years

    Albumin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.

  4. Body Weight

    Time frame: up to 2 years

    Body Weight Change. (kilograms)

  5. Appetite

    Time frame: up to 2 years

    Appetite measured by FAACT

  6. Marker of nutritional status

    Time frame: up to 2 years

    C-reactief proteïne is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.

  7. Marker of nutritional status

    Time frame: up to 2 years

    Lactate dehydrogenase (LDH) is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangyu Kong, associate professor

CONTACT

[email protected]

13564644397

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Apr 3, 2024
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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