Clinical trial · Interventional
Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Platinum-Based Chemotherapy as First-Line Treatment in Participants With Advanced Biliary Tract Carcinoma
NCT07099547CI-TRIAL-00110110recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, open-label, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| ZG005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Text group
- description
- ZG005+Gemcitabine +Cisplatin
- interventionNames
- Drug: ZG005
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Control group
- description
- Tislelizumab+Gemcitabine+Cisplatin
- interventionNames
- Drug: Tislelizumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy of at least 3 months. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.