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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastric Adenocarcinoma; Esophagus Adenocarcinoma; Esophagogastric Junction Adenocarcinoma
• Intervention / Treatment: Drug: XBI-302 + Nivolumab

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: FMT + PD-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	iCR + iPR + iSD rate according to iRECIST criteria	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	iCR + iPR + iSD rate according to iRECIST criteria	6, 12, 18 weeks
Objective response rate	iCR + iPR rate according to iRECIST criteria	24 weeks
Changes of intestinal microbiota characteristics between responders and non-responders	To compare the change of intestinal microbiota characteristics between responders and non-responders	24 weeks
Changes of related immune cells in peripheral blood between responders and non-responders	To compare the change of related immune cells in peripheral blood between responders and non-responders	12 weeks
Change of CD8+T cell counts in tumor tissue between responders and non-responders	To compare the change of CD8+T cell counts in tumor tissue between responders and non-responders	6 weeks
Change of CD8+T cell counts in intestinal tissue between responders and non-responders	To compare the change of CD8+T cell counts in intestinal tissue between responders and non-responders	6 weeks
Incidence and severity of AEs that related to XBI-302	Rate of adverse events and their severity that are determined to be related to XBI-302	24 weeks
Incidence and severity of immune related AEs	Rate and severity of irAEs	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival defined as the time from enrollment to death from any cause	up to 2 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (ACTUAL): August 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nivolumab; Immune Checkpoint Inhibitors
• Other Study ID Numbers: SYLT-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No