An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan/HDS Treatment in Patients with Unresectable Hepatocellular Carcinoma or Intra hepatic Cholangiocarcinoma.

Delcath Systems, Inc0 个研究点目标入组 42 人开始时间: 2014年4月25日最近更新: 2018年2月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 42

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Patients with HCC must meet all of the following criteria for study entry:
•1. HCC diagnosed by tissue or imaging study.
•2. Unresectable HCC without clinically significant extra-hepatic disease (minor lesions [= 1 cm and not consistent with metastatic disease] acceptable) based on computed tomography (CT).
•3. At least one target lesion based on mRECIST. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment or must have progressed after prior treatment if located within previous treatment field.
•4. Child-Pugh Class A.
•5. ECOG PS 0-1.
•6. No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy, including resection, based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imaging.
•7. Age = 18 years.
•8. Signed informed consent.
•Patients with ICC must meet all of the following criteria for study entry:
•1. ICC diagnosed by tissue or imaging study.
•2. Unresectable ICC without clinically significant extra-hepatic disease (minor lesions [= 1 cm and not consistent with metastatic disease] acceptable) based on CT.
•3. At least one target lesion based on mRECIST. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment or must have progressed after prior treatment if located within previous treatment field.
•4. Child-Pugh Class A.
•5. ECOG PS 0-1.
•6. No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy, including resection, based on other technology for ICC, if any, must have been completed at least 4 weeks prior to baseline imaging.
•7. Age = 18 years.
•8. Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 21
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 21

排除标准

•For the HCC cohort, patients for whom transplantation, radiofrequency ablation (RFA), transarterial chemoembolization (TACE), or systemic treatment with sorafenib are better therapeutic options are to be excluded from study entry.
•Additionally, for both the HCC and ICC cohorts, patients who meet any of the following criteria will be excluded from study entry:
•1. Greater than 50% tumor burden in the liver by imaging.
•2. History of orthotopic liver transplantation, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting. Prior Whipple procedure is permitted provided the anatomy is still compatible for perfusion with the Melphalan/HDS system.
•3. Evidence of ascites on imaging study, or the use of diuretics for ascites.
•4. Clinically significant encephalopathy.
•5. History of, or known, hypersensitivity to any components of melphalan or the components of the Melphalan/HDS system.
•6. Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
•7. Received an investigational agent for any indication within 30 days prior to first treatment.
•8. Not recovered from side effects of prior therapy to = Grade 1 (according to National Cancer Institute [NCI] CTCAE version 4.03). Certain side effects that are unlikely to develop into serious or life–threatening events (e.g. alopecia) are allowed at > Grade 1.
•9. Those with New York Heart Association functional classification II, III or IV; active cardiac conditions including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
•10. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
•11. Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism.
•12. Active infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antigen (HBc) positive, or hepatitis B surface antigen (HBsAg) but viral deoxyribonucleic acid (DNA) negative are exception(s).
•13. History of bleeding disorders.
•14. Brain lesions with a propensity to bleed.
•15. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
•16. Previous malignancy within 3 years prior to enrollment, except for curatively-treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, bladder carcinoma in situ or breast cancer in situ.
•17. Inadequate hematologic function as evidenced by any of the following:
•a. Platelets < 90,000/µL
•b. Hemoglobin < 8 g/dL, independent of transfusion or growth factor support
•c. Neutrophils < 1,500 cells/µL.
•18. Serum creatinine > 1.5 mg/dL.
•19. Inadequate liver function as evidenced by any of the following:
•a. Total serum bilirubin = 2.0 mg/dL
•b. Prothrombin time (PT)/international normalized ratio (INR) > 1.5
•c. Aspartate aminotransferase (AST) > 10 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) > 5 times ULN
•d. Serum albumin < 3.0 g/dL.
•20. Known alcohol abuse.
•21. For female subjects of childbearing potential (i.e., have had a menstrual period within the past 12 months): a positive serum pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) within 7 days prior to enrollme

研究者

发起方

Delcath Systems, Inc

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