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

Launched by CHANGHAI HOSPITAL · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of fecal microbiota transplantation (FMT) capsules in patients with advanced gastric cancer. The goal is to see if these capsules, when combined with chemotherapy and a type of therapy called anti-PD-L1 therapy, can be effective and safe for patients whose cancer can't be surgically removed or has spread to other parts of the body. The trial is currently looking for participants aged 18 and older who have a specific type of gastric cancer and can provide tumor tissue for testing.

Eligible participants will have a life expectancy of at least three months and will be able to participate voluntarily by giving their written consent. During the trial, participants will receive treatment and be monitored for any side effects or changes in their condition. It's important to note that individuals with certain health issues, such as severe allergies, active infections, or those currently receiving other experimental treatments, may not be able to participate. Overall, this trial aims to explore a new potential treatment option for patients facing advanced gastric cancer.

Gender

ALL

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