This is a prospective, multicenter, single-arm, phase II clinical study designed to explore the efficacy and safety of zanidatamab in combination with liposomal irinotecan and capecitabine as second-line therapy for HER2-positive advanced biliary tract cancer. Fifteen patients with unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer, will be enrolled after progression on or intolerance to first-line therapy. HER2 positivity must be confirmed by immunohistochemistry and/or fluorescence in situ hybridization, defined as IHC 3+ or IHC 2+ with FISH-confirmed amplification. Zanidatamab 20 mg/kg will be administered intravenously on Day 1 every 2 weeks; liposomal irinotecan 50 mg/m² will be administered intravenously over 90 minutes on Day 2 every 2 weeks; and capecitabine 1,000 mg/m² will be administered orally twice daily on Days 1-10 of each 14-day cycle. Chemotherapy will be administered for a maximum of six cycles, and study treatment will continue until disease progression or unacceptable toxicity. The primary endpoint is objective response rate, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.
Informed consent: Voluntary provision of written informed consent; age ≥18 years.
Pathologic diagnosis: Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer.
HER2 status: HER2 positivity confirmed by immunohistochemistry and/or fluorescence in situ hybridization, defined as IHC 3+ or IHC 2+ with FISH-confirmed amplification. Local test results from each participating center will be used for eligibility screening.
Disease progression after or intolerance to a standard first-line regimen containing a programmed cell death protein 1 or programmed death-ligand 1 inhibitor.
History of malignancy: Another active malignancy within the previous 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
Tumor type: Ampullary carcinoma.
Uncontrolled pleural effusion, ascites, or pericardial effusion. Patients requiring drainage only may be enrolled if there is no clinically significant reaccumulation within 3 days after drainage is discontinued.
Known active central nervous system metastases and/or carcinomatous meningitis.
Single group
Zanidatamab
DrugZanidatamab 20 mg/kg will be administered intravenously on Day 1 every 2 weeks; liposomal irinotecan 50 mg/m² will be administered intravenously on Day 2 every 2 weeks; and capecitabine 1,000 mg/m² will be administered orally twice daily on Days 1-10 of each 14-day cycle. Chemotherapy will be administered for a maximum of six cycles, and study treatment will continue until disease progression or unacceptable toxicity.
Objective response rate as assessed by RECIST v 1.1
Disease control rate as assessed by RECIST v1.1
duration of response as assessed by RECIST v1.1
progression-free survival as assessed by RECIST v1.1
overall survival
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