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Study of FMT Combined With Nivolumab in Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma, Esophagus Adenocarcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
XBI-302 + Nivolumab
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XBI-302 + Nivolumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria

Secondary Outcome Measures

Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
Objective response rate
iCR + iPR rate according to iRECIST criteria
Changes of intestinal microbiota characteristics between responders and non-responders
To compare the change of intestinal microbiota characteristics between responders and non-responders
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
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
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
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
Incidence and severity of immune related AEs
Rate and severity of irAEs

Full Information

First Posted
July 26, 2021
Last Updated
October 19, 2021
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05001360
Brief Title
Study of FMT Combined With Nivolumab in Gastric Cancer
Official Title
Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
We could not get the IRB approval.
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma, Esophagus Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XBI-302 + Nivolumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
XBI-302 + Nivolumab
Other Intervention Name(s)
FMT + PD-1 inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease control rate
Description
iCR + iPR + iSD rate according to iRECIST criteria
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Disease control rate
Description
iCR + iPR + iSD rate according to iRECIST criteria
Time Frame
6, 12, 18 weeks
Title
Objective response rate
Description
iCR + iPR rate according to iRECIST criteria
Time Frame
24 weeks
Title
Changes of intestinal microbiota characteristics between responders and non-responders
Description
To compare the change of intestinal microbiota characteristics between responders and non-responders
Time Frame
24 weeks
Title
Changes of related immune cells in peripheral blood between responders and non-responders
Description
To compare the change of related immune cells in peripheral blood between responders and non-responders
Time Frame
12 weeks
Title
Change of CD8+T cell counts in tumor tissue between responders and non-responders
Description
To compare the change of CD8+T cell counts in tumor tissue between responders and non-responders
Time Frame
6 weeks
Title
Change of CD8+T cell counts in intestinal tissue between responders and non-responders
Description
To compare the change of CD8+T cell counts in intestinal tissue between responders and non-responders
Time Frame
6 weeks
Title
Incidence and severity of AEs that related to XBI-302
Description
Rate of adverse events and their severity that are determined to be related to XBI-302
Time Frame
24 weeks
Title
Incidence and severity of immune related AEs
Description
Rate and severity of irAEs
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
OS
Description
Overall survival defined as the time from enrollment to death from any cause
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of FMT Combined With Nivolumab in Gastric Cancer

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