jRCT2091220423已完成不适用
A clinical trial of DS-8201a for HER2 positive unresectable or recurrent biliary tract cancer: NCCH1805, HERB trial (HERB Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- Overall response rate
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
入选标准
- •1.Adenocarcinoma or adenosquamous carcinoma is histologically diagnosed.
- •2.HER2-expressing was confirmed by central pathological examination of designated HER2 screening trial. HER2-expressing is defined as any of the following:
- •More than or equal to 1+ by IHC
- •Positive by ISH
- •3.Unresectable or recurrent biliary tract cancer.
- •4.No moderate or severe ascites.
- •5.There is no evidence of carcinomatous meningitis, symptomatic brain metastases, or spinal metastases requiring surgical intervention.
- •6.20 years or older.
- •7.The ECOG Performance status(PS) is either 0 or
- •8.Measurable lesions are present.
- •9.Refractory or intolerant to treatment, including Gemcitabine.
- •10.Within 14 days prior to enrollment, the subject has not received systemic steroid therapy in excess of equivalent to 10 mg daily of prednisolone or immunosuppressive drugs.
- •11.Has not received anticancer drugs within 14 days before enrollment or any other investigational drugs within 21 days before enrollment.
- •12.Not undergoing surgery within 28 days prior to enrollment.
- •13.Has not received radiation therapy within 28 days prior to enrollment.
- •14.Left ventricular ejection fraction (LVEF) of > 50%.
- •15.The most recent test values within 14 days before enrollment meet all of the following:
- •Neutrophil count ≧ 1,500/mm3
- •Hemoglobin ≧ 9.0 g/dL
- •Platelet count ≧ 100,000/mm3
- •Total Bilirubin ≦ 1.5 mg/dL
- •AST ≦ 100 IU/L
- •ALT ≦ 100 IU/L
- •Creatinine clearance ≧ 30 mL/min
- •16.They have agreed to a contraceptive at least 4.5 months after the last administration of the investigational product.
- •17.Written informed consent.
排除标准
- •1.Having an active double cancer
- •2.Having a history/complication of symptomatic congestive heart failure within 6 months prior to enrollment or serious arrhythmias requiring treatment
- •3.Having a history/complication of myocardial infarction or unstable angina within 6 months prior to enrollment
- •4.Corrected QT interval (QTcF) > 470 ms (women) or QTcF > 450 ms (men) on 12-lead ECG
- •5.Having non-infectious interstitial lung disease or pneumonitis requiring steroid therapy. Complicated by interstitial lung disease or pneumonitis. Or these lung diseases cannot be ruled out by imaging during the screening period
- •6.Having uncontrolled infections that requiring IV injection of antibiotics, antivirals, or antifungal drugs
- •7.Positive for HIV antibodies, HTLV-1 antibodies, HBsAg, or HCV antibodies
- •8.Negative for HBsAg, positive for anti-HBs or anti-HBc, and positive HBV-DNA assay
- •9.Adverse events considered related to prior therapy that are not recovered to Grade 1 or less except alopecia
- •10.Hypersensitivity to the active ingredient of the investigational product has been confirmed
- •11.Women who are pregnant, breastfeeding, or who may be pregnant
- •12.Combined psychosis or psychiatric symptoms that are considered difficult to participate in the study
- •13.Because of drug allergy, neither iodine nor gadolinium drugs can be used.
结局指标
主要结局
Overall response rate
Overall response rate in HER2 3+(IHC), or HER2 2+(IHC) and ISH positive patients by central imaging review
次要结局
- Progression-free survival
- Overall survival
- Overall response rate in all HER2-expressing patients by central imaging review
- Overall response rate in HER2 low expressing patients by central imaging review
- Incidence of adverse events
- Overall response rate by local investigator review
- Disease control rate
研究者
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