Study of FMT Combined With Nivolumab in Gastric Cancer

Gastric Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05001360
• Other study ID #: SYLT-022
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma
• Esophagus Adenocarcinoma
• Gastric Adenocarcinoma

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