Study of FMT Combined With Nivolumab in Gastric Cancer

• Status: Withdrawn
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Immune Checkpoint Inhibitors; Nivolumab

Criteria

Inclusion Criteria:

• Voluntarily participate in this study and provide written informed consent

• Age ≥ 18 years and ≤70 years, male or female

• Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies

• 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:

• History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin

• Had systemic diseases that were difficult to control within 4 weeks prior to screening

• History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy

• History of coagulation disorders

• Mechanical or paralytic obstruction of the gastrointestinal tract

• Anticipated to receive a great number of antibiotics during study period