Biliary Tract Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGZG005
ZG005 20 mg/kg IV Q3W
DRUGTislelizumab
Tislelizumab 200mg IV Q3W
DRUGGemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
DRUGCisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) | Up to 2 years |
Countries
China
Contacts
CONTACTBo Liu
STUDY_CHAIRJason Wu
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Outcome results
None listed