About this trial
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.
Eligibility criteria
Qualifiers
Males or females aged ≥18 years;
Histologically confirmed HER2-positive metastatic biliary tract cancer;
ECOG performance status of 0 to 1;
No prior treatment with anti-HER2 therapies;
Disqualifiers
Known allergy or contraindication to any component of the study drugs;
Previous treatment with anti-HER2 therapies;
Prior use of immunotherapy;
Known active central nervous system metastases or carcinomatous meningitis;
Trial design
Treatments tested in this trial
- Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor
Treatment groups
Locations
Sponsors and collaborators
Eastern Hepatobiliary Surgery Hospital
Lead sponsor