Unresectable Locally Advanced or Metastatic Biliary Tract Cancer
Conditions
Interventions
HER2 1+:None
HER2 2+:None
HER2 3+:None
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Confirmed as unresectable locally advanced (AJCC 8th edition, Stage IV) or metastatic biliary tract cancer (BTC) by histopathology or cytology, with clear subtypes (e.g., gallbladder cancer, intrahepatic cholangiocarcinoma [iCCA], extrahepatic cholangiocarcinoma [eCCA]). 2 Presence of HER2 expression, with the test specimen derived from the primary tumor or metastatic lesion (primary tumor preferred); the interval between the detection time and the start of treatment = 1 line of systemic therapy for advanced BTC. 4 Aged >= 18 years, regardless of gender. 5 Complete clinical data (availability of baseline data, treatment information, and results of at least 1 efficacy assessment).
Exclusion criteria
Exclusion criteria: 1 Concomitant with other active malignant tumors. 2 Definite contraindications (e.g., severe allergic history) to the therapeutic drugs used in the study, including but not limited to zanidatamab, immune checkpoint inhibitors, and chemotherapeutic agents. 3 Occurrence of severe cardiovascular events (e.g., myocardial infarction, heart failure) within 6 months before the start of treatment. 4 Severe lack of clinical data (e.g., no HER2 detection results, no baseline imaging evaluation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); ;Overall Survival (OS); ;Adverse Event Rate; | — |
Countries
China
Contacts
Public ContactJianbo Chen
The First Affiliated Hospital of Xiamen University
Outcome results
None listed