Clinical trial · Interventional
Study of FMT Combined With Nivolumab in Gastric Cancer
Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
NCT05001360CI-TRIAL-00054688withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We could not get the IRB approval.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagogastric Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Esophagus Adenocarcinoma | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XBI-302 + Nivolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XBI-302 + Nivolumab
- description
- 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.
- interventionNames
- Drug: XBI-302 + Nivolumab
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- 24 weeks
- description
- iCR + iPR + iSD rate according to iRECIST criteria
Secondary outcomes (8)
- measure
- Disease control rate
- timeFrame
- 6, 12, 18 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.