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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06346093
Other study ID # CHEC2024-089
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2024
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Changhai Hospital
Contact Xiangyu Kong, associate professor
Phone 13564644397
Email xiangyukong185@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Fecal Microbiota Transplantation Capsules
FMT Capsules in Combination with Chemotherapy and Anti-PD-L1 Therapy
Placebo
Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules

Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Marker of nutritional status Hemoglobin is a measure of the nutritional status and are seen as markers for the catabolic state of cachectic cancer patients. up to 2 years
Other Marker of nutritional status Creatinin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients. up to 2 years
Other Marker of nutritional status Albumin is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients. up to 2 years
Other Body Weight Body Weight Change. (kilograms) up to 2 years
Other Appetite Appetite measured by FAACT up to 2 years
Other Marker of nutritional status C-reactief proteïne is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients. up to 2 years
Other Marker of nutritional status Lactate dehydrogenase (LDH) is a measure of the nutritional status and is seen as markers for the catabolic state of cachectic cancer patients. up to 2 years
Primary 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
Primary 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 Progression-free Survival (PFS) 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. up to 2 years
Secondary Overall Survival (OS) The length of time (in days) from study intervention that participants remain alive. up to 2 years
Secondary Incidence of Adverse Events Related to Treatment All adverse events and their relationships to study drugs and procedures will be recorded,to assess overall safety, feasibility and tolerability of treatment. up to 6 months
Secondary Change in the intestinal microbiome community Mean change from baseline of bacterial species compared with 6 months post fecal microbiota transplantation (FMT). up to 6 months
Secondary Quality of life based on the questionnaire The EQ-5D-5L questionnaire will be used to assess the quality of life of the participants. up to 2 years
Secondary Quality of life based on the questionnaire The FACT-GA questionnaire will be used to assess the quality of life of the participants. up to 2 years
Secondary Change in the immunity Mean change from baseline of immune cells compared with 6 months post fecal microbiota transplantation (FMT). up to 6 months
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