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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05001360
Other study ID # SYLT-022
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date November 2023

Study information

Verified date July 2021
Source Fujian Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Fujian Cancer Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other OS Overall survival defined as the time from enrollment to death from any cause up to 2 years
Primary Disease control rate iCR + iPR + iSD rate according to iRECIST criteria 24 weeks
Secondary Disease control rate iCR + iPR + iSD rate according to iRECIST criteria 6, 12, 18 weeks
Secondary Objective response rate iCR + iPR rate according to iRECIST criteria 24 weeks
Secondary Changes of intestinal microbiota characteristics between responders and non-responders To compare the change of intestinal microbiota characteristics between responders and non-responders 24 weeks
Secondary 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 12 weeks
Secondary 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 6 weeks
Secondary 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 6 weeks
Secondary Incidence and severity of AEs that related to XBI-302 Rate of adverse events and their severity that are determined to be related to XBI-302 24 weeks
Secondary Incidence and severity of immune related AEs Rate and severity of irAEs 24 weeks
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