NCT05001360

Study of FMT Combined With Nivolumab in Gastric Cancer

Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer. During treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.

Conditions

• Gastric Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma
• Esophagus Adenocarcinoma

Interventions

Type	Name	Description
DRUG	XBI-302 + Nivolumab	After gut preparation, a single dose of FMT will be performed via oral administration. Subsequently, nine combined treatment cycles that composed of anti-PD-1 infusions (Nivolumab at 240 mg, q2w) and additional FMT capsules, and 3 single treatment cycles of anti-PD-1 infusions will be administered.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2021-08-11
• Last updated: 2021-10-27

Locations

1 site across 1 country: China