ZG005 with gemcitabine and cisplatin for advanced gallbladder cancer
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
This test tries whether adding ZG005 to gemcitabine and cisplatin helps people with advanced gallbladder cancer as their first treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07099547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People with histologically or cytologically confirmed gallbladder cancer who have ECOG performance status 0–1, a life expectancy of at least three months, and can give informed consent are appropriate candidates.
Not a fit: Patients with poor performance status, major comorbidities, or who cannot tolerate platinum‑based chemotherapy are unlikely to receive benefit from this regimen.
Why it matters
Potential benefit: If successful, adding ZG005 could improve tumor control and delay disease progression compared with chemotherapy alone.
How similar studies have performed: Previous trials combining PD‑1/PD‑L1 inhibitors with gemcitabine and cisplatin in biliary tract cancers have shown benefit, so this approach builds on promising prior results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.