Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
NCT ID: NCT07099547
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-09-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Text group
ZG005+Gemcitabine +Cisplatin
ZG005
ZG005 20 mg/kg IV Q3W
Gemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
Cisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Control group
Tislelizumab+Gemcitabine+Cisplatin
Tislelizumab
Tislelizumab 200mg IV Q3W
Gemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
Cisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Interventions
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ZG005
ZG005 20 mg/kg IV Q3W
Tislelizumab
Tislelizumab 200mg IV Q3W
Gemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
Cisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Wu
Role: STUDY_CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Lianxin Liu
Role: primary
Other Identifiers
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ZG005-007
Identifier Type: -
Identifier Source: org_study_id
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