CTRI/2021/01/030657招募中2 期
Capecitabine and Erlotinib in advanced Hepatocellular Carcinoma (HCC) after Sorafenib failure (CAPER- HCC study) - a single arm, prospective phase II clinical trial. - CAPER- HCC study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
- •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.Histological or cytological confirmation of HCC (hepatocellular carcinoma) or radiologically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases criteria in patients with a confirmed diagnosis of cirrhosis.
- •3.Failure to prior treatment with Sorafenib (defined as clinical or radiological progression) or experiencing grade 3/4 toxicities on Sorafenib.
- •4.Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation or chemoembolization.
- •5.Liver function status Child-Pugh (CTP) score <=7. (Child Pugh status will be calculated based on clinical findings and laboratory results during the screening period).
- •6.Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >=4 weeks before first dose of study medication.
- •7.Age18 years or older with Eastern Cooperative Oncology Group Performance Status of 0 to 2.
- •8.Participants must have normal organ and marrow function as defined below within 15 days before starting study medication:
- •â??Neutrophils>=1,500/mcL
- •â??Platelets>=60,000/mcL
- •â??Haemoglobin >=8.0 g/dl
- •â??Total bilirubin<=3 Ã? institutional upper limit of normal
- •â??AST(SGOT)/ALT(SGPT) <= 3 Ã? institutional upper limit of normal
- •â??Albumin levels of >= 2.5 mg/dl
- •â??Calculated Creatinine clearance >= 30 ml/min
- •9.At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC. Tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
- •10.Life expectancy of at least 3 months.
- •11.Negative serum pregnancy test (if applicable) and willing for adequate contraception
排除标准
- •1.Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 5.0. Hepatitis B and Hepatitis C will be allowed.
- •2.Fibrolamellar hepatocellular carcinoma.
- •3.Patients unable to swallow oral medications.
- •4.Patients has pulmonary fibrosis, or pulmonary interstitial disease.
- •5.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.
- •6.History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis. Screening with CNS imaging studies computed tomography or magnetic resonance imaging is required only if clinically indicated.
- •7.Known hypersensitivity or contraindications against erlotinib or capecitabine.
- •8.Patients with a history of liver transplant; gastric varices not amenable to ablative therapy; ascites or encephalopathy refractory to medical management; bleeding from esophageal or gastric varices during the 3 months before study participation or other poorly controlled medical conditions.
研究者
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