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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Fujian Cancer Hospital
Fuzhou, Fujian, China
Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
Time frame: 24 weeks
Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
Time frame: 6, 12, 18 weeks
Objective response rate
iCR + iPR rate according to iRECIST criteria
Time frame: 24 weeks
Changes of intestinal microbiota characteristics between responders and non-responders
To compare the change of intestinal microbiota characteristics between responders and non-responders
Time frame: 24 weeks
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
Time frame: 12 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
Incidence and severity of AEs that related to XBI-302
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Rate of adverse events and their severity that are determined to be related to XBI-302
Time frame: 24 weeks
Incidence and severity of immune related AEs
Rate and severity of irAEs
Time frame: 24 weeks