Using fecal microbiota transplantation to treat advanced gastric cancer
A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer
NA · Changhai Hospital · NCT06346093
This study is testing if giving patients with advanced gastric cancer special capsules made from healthy gut bacteria, along with their regular cancer treatments, can help them feel better and improve their chances of recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital (other) |
| Drugs / interventions | prednisone, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06346093 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of fecal microbiota transplantation (FMT) capsules in combination with chemotherapy and anti-PD-L1 therapy for patients with advanced gastric cancer. It is a randomized, double-blind, placebo-controlled trial, meaning participants will be assigned to either receive the FMT capsules or a placebo without knowing which they are receiving. The study aims to determine if FMT can enhance treatment outcomes in patients with locally advanced, unresectable, or metastatic gastric adenocarcinoma. Participants must provide tumor tissue and have measurable disease to qualify.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced gastric adenocarcinoma who can provide tumor tissue and have a good performance status.
Not a fit: Patients with contraindications to fecal microbiota transplantation or those currently receiving systemic antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other conditions, its application in advanced gastric cancer is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Xiangyu Kong, associate professor
- Email: xiangyukong185@hotmail.com
- Phone: 13564644397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Gastric Cancer