Trials Sponsors Conditions Drugs Pricing

Conditions

Esophagogastric Junction Adenocarcinoma Esophagus Adenocarcinoma Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
24 weeks

Secondary Outcomes (8)

Disease control rate
6, 12, 18 weeks
Objective response rate
24 weeks
Changes of intestinal microbiota characteristics between responders and non-responders
24 weeks
Changes of related immune cells in peripheral blood between responders and non-responders
12 weeks
Change of CD8+T cell counts in tumor tissue between responders and non-responders
6 weeks
+3 more secondary outcomes

Other Outcomes (1)

OS
up to 2 years

Study Arms (1)

XBI-302 + Nivolumab

EXPERIMENTAL

FMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks.

Drug: XBI-302 + Nivolumab

Interventions

XBI-302 + NivolumabDrug

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.

Also known as: FMT + PD-1 inhibitor

XBI-302 + Nivolumab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
XBI-302 + Nivolumab
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily participate in this study and provide written informed consent
Age ≥ 18 years and ≤70 years, male or female

Sponsors & Collaborators

Fujian Cancer Hospital
Governmentlead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

NivolumabFecal Microbiota TransplantationImmune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum Globulins

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 11, 2021

Study Start

October 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Study of FMT Combined With Nivolumab in Gastric Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (1)

Study Arms (1)

XBI-302 + Nivolumab

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Other Outcomes (1)

Study Arms (1)

XBI-302 + Nivolumab

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations