Hepatocellular Carcinoma (HCC) MedDRA version: 17.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ThermoDox®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin hydrochloride (in heat-sensitive liposomes)
CAS Number: 25316-40-9
Other descripti
Sponsors
Celsion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following inclusion criteria to be eligible to participate in the study. Subjects may be randomized without a biopsy if they meet American Association for the Study of Liver Disease (AASLD) criteria for the diagnosis of HCC (see Appendix 20.8). Subjects not meeting AASLD criteria for HCC will need a biopsy for confirming HCC prior to randomization. 1. Male or female = 18 years of age 2. Diagnosed with a single HCC lesion = 3.0 cm but = 7.0 cm in maximum diameter based on diagnosis at screening. • Subjects meeting the AASLD criteria may be randomized without a biopsy, but will undergo a biopsy during the RFA procedure unless contraindicated or unattainable. •Subjects not meeting the AASLD criteria for HCC will need a biopsy to confirm HCC prior to randomization. 3. Be an appropriate candidate for receiving RFA as a medically indicated treatment as evaluated by the following factors: • The position and accessibility of the target lesion allows for the safe administration of multiple ablation cycles or deployments to achieve a probe dwell time of = 45 minutes. • Not a candidate for surgical resection according to the local guidelines for resection and in the Investigator’s judgment. 4. Child-Pugh Class A without either current encephalopathy or ascites 5. Left ventricular ejection fraction (LVEF) = 50% 6. ECOG performance status 0 7. Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution. 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Is scheduled for liver transplantation. 2. Expected ablation volume > 30% of total liver volume or removal of 3 hepatic segments 3. More than 1 lesion identified during baseline. 4. Have previously received therapeutic treatment for HCC outside the study protocol or is expected to receive concomitant HCC treatment prior to PFS event. 5. Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias. 6. Have previously received any anthracycline outside the protocol. 7. Have extrahepatic metastasis. 8. Have portal or hepatic vein tumor invasion/thrombosis. 9. Have body temperature > 101ºF (38.3ºC) immediately prior to study treatment. 10. Baseline laboratories (repeat lab tests are permitted to evaluate eligibility during the Screening Period. Lab results must be within protocol range prior to study treatment.) • Absolute neutrophil count 3.0 mg/dL. • Serum albumin 1.5 times the institution's upper normal limit (UNL), except in subjects, who are therapeutically anticoagulated for medical conditions unrelated to HCC such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld. 16. Have contraindications to receiving doxorubicin HCl. 17. Are being treated with other investigational agents. 18. Use of an investigational drug outside this study within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication. 19. Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection. 20. HIV positive. 21. NYHA class III or IV functional classification for heart failure. 22. Evidence of hemachromatosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare overall survival (OS) between patients receiving RFA plus ThermoDox versus RFA alone, using a standardized Radiofrequency Ablation (sRFA) treatment dwell time = 45 minutes.;Secondary Objective: The secondary objectives are to compare progression-free survival (PFS) and safety between patients receiving sRFA plus ThermoDox versus sRFA alone, using a standardized RFA treatment dwell time = 45 minutes.;Primary end point(s): Primary Endpoint: Survival All patients will be monitored for survival by recording their visits during routine follow up for response to treatment. The visits are scheduled to occur every four months from the first imaging study confirming complete ablation until month 25 or radiological progression, whichever comes first. If patients have not demonstrated radiological progression at month 25 then the imaging visit schedule is reduced to every six months until progression. Survival is confirmed at every imaging visit. Once radiological progression is confirmed then follow up for overall survival is required. Sites are required to confirm contact with the subject during either a clinic visit or a telephone contact every three months. It is expected that subject follow up will be about five years. ;Timepoint(s) of evaluation of this end point: Overall Survival Evaluation at every imaging visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoint: Progression Free Survival The protocol incorporates modified RECIST (mRECIST) developed for HCC clinical research as a basis to evaluate tumor response. The mRECIST enables assessment of overall response by taking into account target lesion response, and presence or absence of new lesions. A separate imaging manual and imaging training program has been developed for this study in order to ensure uniformity in imaging technique and imaging review in accordance with mRECIST. ;Timepoint(s) of evaluation of this end point: Progression Free Survival | — |
Countries
Canada, China, Germany, Hong Kong, Italy, Korea, Republic of, Malaysia, Philippines, Spain, Taiwan, Thailand, United States
Contacts
Public ContactDirector, Clinical Operations
Celsion Corporation
Outcome results
None listed