Clinical trial NCT05001360: Study of FMT Combined With Nivolumab in Gastric Cancer
Official title: Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastric Adenocarcinoma
Esophagogastric Junction Adenocarcinoma
Esophagus Adenocarcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease control rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Disease control rate
timeFrame: 6, 12, 18 weeks
measure: Objective response rate
timeFrame: 24 weeks
measure: Changes of intestinal microbiota characteristics between responders and non-responders
timeFrame: 24 weeks
measure: Changes of related immune cells in peripheral blood between responders and non-responders
timeFrame: 12 weeks
measure: Change of CD8+T cell counts in tumor tissue between responders and non-responders
timeFrame: 6 weeks
measure: Change of CD8+T cell counts in intestinal tissue between responders and non-responders
timeFrame: 6 weeks
measure: Incidence and severity of AEs that related to XBI-302
timeFrame: 24 weeks
measure: Incidence and severity of immune related AEs
timeFrame: 24 weeks
Other outcomes:
measure: OS
timeFrame: up to 2 years
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References: