Study of FMT Combined With Nivolumab in Gastric Cancer

Fujian Provincial Cancer Hospital

Status: Withdrawn

Conditions: Esophagus Adenocarcinoma; Esophagogastric Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Drug: XBI-302 + Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05001360

SYLT-022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

XBI-302 + Nivolumab

Experimental group

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.

Treatment:

Drug: XBI-302 + Nivolumab