Esophagogastric Junction Adenocarcinoma, Esophagus Adenocarcinoma, Gastric Adenocarcinoma
Conditions
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.
Interventions
DRUGXBI-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.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 24 weeks | iCR + iPR + iSD rate according to iRECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 6, 12, 18 weeks | iCR + iPR + iSD rate according to iRECIST criteria |
| Objective response rate | 24 weeks | iCR + iPR rate according to iRECIST criteria |
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence and severity of immune related AEs | 24 weeks | Rate and severity of irAEs |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 2 years | Overall survival defined as the time from enrollment to death from any cause |
Countries
China
Outcome results
None listed