ZG005 with gemcitabine and cisplatin for advanced gallbladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label phase II study gives ZG005 combined with standard gemcitabine and cisplatin as first-line therapy to participants with advanced gallbladder cancer. Participants are randomized and followed for tumor response, progression-free and overall survival, safety, pharmacokinetics, and immunogenicity. Clinical and laboratory data will be collected to characterize adverse events and drug levels over time. Enrollment and treatment are conducted at a single academic center in Hefei, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Bo Liu
• Email: liub@zelgen.com
• Phone: +86-0512-57309965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.