Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG005, Tislelizumab, Gemcitabine, Cisplatin.
- Who it may be relevant to
- Registry conditions: Biliary Tract Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug ZG005
ZG005 20 mg/kg IV Q3W - Drug Tislelizumab
Tislelizumab 200mg IV Q3W - Drug Gemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle. - Drug Cisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Primary outcome measures
- Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Adverse Events (AEs) [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
Identifiers
NCT: NCT07099547 · ZG005-007