Hepatocellular Carcinoma Clinical Trial
— OPTIMAOfficial title:
A Phase III, Randomized, Double Blind, Dummy-Controlled Study of ThermoDox® (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3 cm to ≤ 7 cm
Verified date | October 2018 |
Source | Celsion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).
Status | Completed |
Enrollment | 556 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 American Association for the Study of Liver Disease (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. Eastern Cooperative Oncology Group (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. Exclusion Criteria: 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 < 1500/mm3 - Platelet count < 75,000/mm3 - Hgb < 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure) Note: If clinically indicated, subjects may receive platelets or packed red blood cell (RBC) transfusions and be re-evaluated after condition is treated. 11. Baseline Chemistry - Serum creatinine = 2.5 mg/dL or calculated creatinine clearance (CrCl) =25.0 mL/min. - Serum bilirubin > 3.0 mg/dL. - Serum albumin < 2.8 g/dL. 12. Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents that prohibit the ability to complete the imaging requirements. 13. Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment. 14. Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control). 15. Have INR > 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 hydrochloride (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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
China | 302 Military Hospital of China | Beijing | |
China | Beijing Cancer Hospital, School of Oncology, Peking | Beijing | |
China | Beijing Hospital of the Ministry of Health | Beijing | |
China | Chinese PLA General Hospital | Beijing | |
China | Peking University First Hospital | Beijing | |
China | West China Hospital of Sichuan University | Chengdu | |
China | The Second Hospital of Dalian Medical University | Dalian | |
China | Mengchao Hepatobiliary Hospital of Fujian Medicatl University | Fuzhou | Fujian |
China | Guangdong General Hospital | Guangdong | |
China | Hunan Cancer Hospital | Hunan | |
China | The First Hospital of Jilin University | Jilin | |
China | Xijing Hospital | Shaanxi Province | |
China | Zhongshan Hospital, Fudan University | Shanghai | |
China | The Sixth People's Hospital of Shenyang | Shenyang | |
China | The 3rd Hospital of Tianjing | Tianjin | |
China | The First Hospital of Zhejiang | ZheJiang | |
China | Zhejiang Cancer Hospital | Zhejiang | |
Germany | Institut für Diagnostische und Radiologische Therapie del Uniklinik Frankfurt | Frankfurt | |
Germany | Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik (Gastroenterologie) | München | |
Germany | Universitätsklinikum Regensburg, Institut für Röntgendiagnostik | Regensburg | |
Germany | Universitaetsklinikum des Saarlandes, Klik fuer Allgemeine Chirurgie, Viszeral-, Gefaess und Kinderchirurgie | Saar | |
Hong Kong | Queen Mary Hospital | Hong Kong | |
Italy | Cisanello Hospital, Division of Diagnostic Imaging and Intervention | Pisa | |
Italy | Department of Radiological Sciences and Bioimaging Catholic University of Rome, "A. Gemelli" Hospital | Rome | |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Kyungpook National University Medical Center | Daegu | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Philippines | Chinese General Hospital and Medical Center | Manila | |
Philippines | St. Lukes Medical Center | Quezon City | |
Philippines | Cardinal Santos Medical Center | San Juan | |
Singapore | Singapore General Hospital | Singapore | |
Spain | Hospital Madrid Norte Sanchinarro | Madrid | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
Taiwan | National Taiwan University Hospital, Yun-Lin Branch | Douliou City | |
Taiwan | Chang Gung Memorial Hospital - Kaohsiung | Kaohsiung | |
Taiwan | Taipei Medical University-Shuang Ho Hospital | New Taipei City | |
Taiwan | Taichung Veteran General Hospital | Taichung | |
Taiwan | National Cheng Kung University (NCKU) Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei City | |
Taiwan | Chang Gung Memorial Hospital - Linkou | Taoyuan | |
Thailand | Siriraj Hospital | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | |
Thailand | Srinagarind Hospital | Khon Kaen | |
Thailand | Thammasat University Hospital | Pathumthani | |
Thailand | Songklanagarind Hospital | Songkhla | |
United States | UCLA Department of Medicine | Los Angeles | California |
Vietnam | 108 Military Central Hospital | Hà N?i | Hai Ba Trung District |
Vietnam | Bach Mai Hospital | Hà N?i | Dong Da District |
Vietnam | Bach Mai Hospital (Hepato-gastroenterology Department) | Hanoi | |
Vietnam | Can Tho Oncology Hospital | Hanoi | |
Vietnam | National Cancer Hospital | Hanoi | |
Vietnam | Viet Duc University Hospital | Hanoi | |
Vietnam | People's Hospital 115 | Ho Chi Minh City | |
Vietnam | Hue Central Hospital | Hu? | Vin Ninh Ward |
Lead Sponsor | Collaborator |
---|---|
Celsion |
United States, Vietnam, Canada, China, Germany, Hong Kong, Italy, Korea, Republic of, Malaysia, Philippines, Singapore, Spain, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Overall survival is defined as the time (in months) from the date of randomization to the death date. | 5 years | |
Secondary | Progression-free survival (PFS) | Progression-free survival is defined as the time (in months) from the date of randomization until the date of the Investigator-assessed radiological disease progression or death due to any cause. | 5 years |
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