Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-10-31
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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SYLT-022
Identifier Type: -
Identifier Source: org_study_id