CTRI/2023/07/055785尚未招募2 期
Trastuzumab emtansine as second-line therapy in HER2 positive Advanced Biliary tract cancers -single arm prospective phase II clinical trial(TAB-3 trial) - TAB-3 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histologically confirmed adenocarcinoma of the biliary tract (including gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma), with the following specifications
- •1.Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.
- •2.Patients who have progressed on gemcitabine-based first-line therapy, or relapsed within 6 months of stopping gemcitabine or capecitabine or S1 based regime if used as adjuvant therapy.
- •3.HER2 positive by IHC as per criteria used for gastric cancers.
- •4.Age 18 to 75 years with ECOG PS 0-2.
- •5.The patient does not have any contraindications to receiving trastuzumab emtansine.
- •6.Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) greater than or equal to 50% or above the lower limit of normal. ECG with no clinically relevant abnormalities.
- •7.Women of childbearing age should have a negative pregnancy test at the time of enrolment and should be willing to use adequate contraception during the treatment phase of the trial.
- •8.Unresectable or metastatic cancer.
- •9.Adequate hematological, hepatic, and renal function parameters-
- •Hematological Hb more than 80 g per L, ANC more than or equal to 1.5 x 109per L, platelets more than or equal to 100 x 109 per L.
- •Liver functions- bilirubin less than or equal to 2 x upper limit normal (ULN), AST and ALT less than or equal to 5 x ULN, alkaline phosphatase less than or equal to 6 x upper limit normal (ULN) S. albumin more than or equal to 30 g per L.
- •Renal function- Creatinine less than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 30 mL per min.
- •10.A life expectancy of at least 12 weeks.
排除标准
- •1.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III to IV, Clinically significant valvular defect.
- •2.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
- •3.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplemental oxygen therapy.
- •4.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study.
- •5.Known hypersensitivity or contraindications against trastuzumab emtansine.
- •6.Clinically significant valvular defect.
- •7.Baseline neuropathy > NCI Grade I.
- •8.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
研究者
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