EUCTR2014-001585-98-IT进行中（未招募）1 期
An International Multi-center Phase 2 Study to Evaluate the Efficacy andSafety of Melphalan/HDS Treatment in Patients with UnresectableHepatocellular Carcinoma or Intra hepatic Cholangiocarcinoma. - An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan/HDS Tre
DELCATH SYSTEMS, INCORPORATIONS0 个研究点目标入组 42 人开始时间: 2018年1月24日最近更新:
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相关药物
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
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: 1
- •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, Whipple's procedure,
- •hepatic vasculature incompatible with perfusion, hepatofugal flow in the
- •portal vein or known unresolved venous shunting.
- •3. Evidence of ascites on imaging study, or the use of diuretics for
- •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
- •17. Inadequate hematologic function as evidenced by any of the
- •a. Platelets < 90,000/µL
- •b. Hemoglobin < 8 g/dL, independent of transfusion or growth factor
- •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
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