Study of FMT Combined With Nivolumab in Gastric Cancer

Not Applicable

Withdrawn

• Conditions: Esophagogastric Junction Adenocarcinoma; Esophagus Adenocarcinoma; Gastric Adenocarcinoma
• Interventions: Drug: XBI-302 + Nivolumab

• Registration Number: NCT05001360
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Study Start: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-27
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XBI-302 + Nivolumab	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 Measures

Name	Time	Method
Disease control rate	24 weeks	iCR + iPR + iSD rate according to iRECIST criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China