Study of FMT Combined With Nivolumab in Gastric Cancer

NCT05001360 | Withdrawn

• 1 other identifier: SYLT-022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma; Esophagogastric Junction Adenocarcinoma; Esophagus Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  iCR + iPR + iSD rate according to iRECIST criteria

  24 weeks

Secondary Outcomes (8)

• Disease control rate

  6, 12, 18 weeks

• Objective response rate

  24 weeks

• Changes of intestinal microbiota characteristics between responders and non-responders

  24 weeks

• Changes 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

  6 weeks

Other Outcomes (1)

• OS

  up to 2 years

Study Arms (1)

XBI-302 + Nivolumab

EXPERIMENTAL

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

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.

Also known as: FMT + PD-1 inhibitor

XBI-302 + Nivolumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Nivolumab; Fecal Microbiota Transplantation; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 11, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)