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
- Conditions
- unresectable hepatocellular carcinoma (HCC) confined to the liver and Intra hepatic Cholangiocarcinoma confined to the liverMedDRA version: 17.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864MedDRA version: 17.1 Level: LLT Classification code 10073077 Term: Intrahepatic cholangiocarcinoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001585-98-GB
- Lead Sponsor
- Delcath Systems, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
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 extrahepatic disease based on CT
3. At least one target lesion based on mRECIST for HCC. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment or having progressed after prior treatment if located within previous treatment field.
4. Child-Pugh Class A
5. Eastern Cooperative Oncology Group Performance Status 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 biopsy and imaging study
2. Unresectable ICC without clinically significant extra hepatic disease 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. ECOG PS 0-1
5. 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
6. Age = 18 years
7. 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
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, 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 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 Common Terminology Criteria for Adverse Events version 4.03 [NCI CTCAE v. 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, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but 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 International Normalized Ratio (INR) > 1.5
c. Aspartate aminotransferase (AST) > 10 times ULN or alanine transaminase (ALT) > 5 times ULN
d. Serum albumin < 3.0 g/dL
Patients with ICC must meet the followin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method