Study of FMT Combined With Nivolumab in Gastric Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT05001360
Status
Withdrawn

Conditions

  • Esophagogastric Junction Adenocarcinoma
  • Esophagus Adenocarcinoma
  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • XBI-302 + Nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2021
Status verified
Jul 2021
Primary completion
Oct 31, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XBI-302 + Nivolumab
    FMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks.

Primary Outcome Measure

Disease control rate [ Time Frame: 24 weeks ]

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