NCT07841873尚未招募2 期
Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors: A Multicenter, Single-arm, Phase II Clinical Study
Anhui Provincial Hospital0 个研究点目标入组 15 人开始时间: 2026年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Objective response rate as assessed by RECIST v 1.1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Prior treatment:
- •Disease progression after or intolerance to a standard first-line regimen containing a programmed cell death protein 1 or programmed death-ligand 1 inhibitor.
- •No prior treatment with irinotecan, capecitabine, or any HER2-targeted therapy.
- •Measurable disease: At least one measurable target lesion according to RECIST version 1.
- •Performance status: Eastern Cooperative Oncology Group performance status of 0 or
- •Life expectancy: ≥12 weeks.
- •Adequate organ function, based on test results obtained within 14 days before the first dose:
- •Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹/L; hemoglobin ≥90 g/L; platelet count ≥100 × 10⁹/L.
- •Hepatic function: Total bilirubin ≤1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal, or ≤5 × the upper limit of normal in patients with liver metastases.
- •Renal function: Serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min.
- •Cardiac function: Left ventricular ejection fraction ≥50%.
- •Coagulation function: International normalized ratio ≤1.5 × the upper limit of normal.
- •Contraception: Patients of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
排除标准
- •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 conditions:
- •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.
- •Recent treatment:
- •Major surgery or radiotherapy within 4 weeks before the first dose.
- •Traditional Chinese medicines with an approved antitumor indication within 2 weeks before the first dose.
- •Participation in another interventional clinical study within 4 weeks before the first dose.
- •Comorbidities:
- •A history of myocardial infarction or unstable angina within 6 months before enrollment; troponin levels meeting diagnostic criteria for myocardial infarction; or clinically significant cardiac disease, including ventricular arrhythmias requiring treatment, uncontrolled hypertension, or any history of symptomatic heart failure.
- •Active infection, including hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
- •Patients positive for hepatitis B surface antigen must have an HBV DNA level <1,000 IU/mL and agree to receive antiviral therapy throughout the study.
- •Hepatitis C virus infection, except that the following patients are eligible: (i) patients with no history of curative antiviral therapy who have a confirmed negative viral load; or (ii) patients who completed curative antiviral therapy ≥12 weeks before enrollment and have a negative viral load.
- •Gastrointestinal conditions: Factors that may affect absorption of oral medication, such as chronic diarrhea or intestinal obstruction; or Grade ≥2 diarrhea.
- •Drug interactions: Use of strong CYP3A4 or UGT1A1 inhibitors or inducers within 3 weeks before the first dose.
- •Adverse reactions: Toxicities from prior therapy that have not recovered to Grade ≤1, except alopecia and peripheral neuropathy of Grade ≤
- •History of a life-threatening hypersensitivity reaction to monoclonal antibodies, recombinant proteins, or any excipient in the zanidatamab formulation.
- •Women who are pregnant or breastfeeding, and women or men planning to conceive a child.
研究组 & 干预措施
Treatment
Experimental
干预措施: Zanidatamab (Drug)
结局指标
主要结局
Objective response rate as assessed by RECIST v 1.1
时间窗: 24 months
次要结局
- overall survival(48 months)
- Adverse Events as Assessed by CTCAE v5.0(24 months)
- Disease control rate as assessed by RECIST v1.1(24 months)
- duration of response as assessed by RECIST v1.1(24 months)
- progression-free survival as assessed by RECIST v1.1(24 months)
研究者
Wang Gang
Chief Physician
Anhui Provincial Hospital
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