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Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC) (OPTIMA)

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ClinicalTrials.gov Identifier: NCT02112656
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Celsion

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: ThermoDox Drug: Dummy infusion Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2014
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
Experimental: ThermoDox 50 mg/m2
ThermoDox plus standardized RFA using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm
Drug: ThermoDox
Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion

Placebo Comparator: Dummy infusion
standardized RFA alone using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm
Drug: Dummy infusion
Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 5 years ]
    Overall survival is defined as the time (in months) from the date of randomization to the death date.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 5 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112656


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Locations
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United States, California
UCLA Department of Medicine
Los Angeles, California, United States, 90095
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada
China, Fujian
Mengchao Hepatobiliary Hospital of Fujian Medicatl University
Fuzhou, Fujian, China, 350005
China
Peking University First Hospital
Beijing, China, 100034
Beijing Cancer Hospital, School of Oncology, Peking
Beijing, China, 100036
302 Military Hospital of China
Beijing, China, 100039
Beijing Hospital of the Ministry of Health
Beijing, China, 100730
Chinese PLA General Hospital
Beijing, China
West China Hospital of Sichuan University
Chengdu, China, 610041
The Second Hospital of Dalian Medical University
Dalian, China, 116023
Guangdong General Hospital
Guangdong, China, 510080
Hunan Cancer Hospital
Hunan, China, 410013
The First Hospital of Jilin University
Jilin, China, 130021
Xijing Hospital
Shaanxi Province, China, 710032
Zhongshan Hospital, Fudan University
Shanghai, China, 200032
The Sixth People's Hospital of Shenyang
Shenyang, China, 110006
The 3rd Hospital of Tianjing
Tianjin, China, 300170
The First Hospital of Zhejiang
ZheJiang, China, 310013
Zhejiang Cancer Hospital
Zhejiang, China, 310022
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, Germany, 66421
Hong Kong
Queen Mary Hospital
Hong Kong, 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, Italy
Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 702-210
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137-701
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Philippines
Chinese General Hospital and Medical Center
Manila, Philippines, 1003
St. Lukes Medical Center
Quezon City, Philippines, 1112
Cardinal Santos Medical Center
San Juan, Philippines, 1503
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Spain
Hospital Madrid Norte Sanchinarro
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliou City, Taiwan, 640
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung, Taiwan, 833
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 235
Taichung Veteran General Hospital
Taichung, Taiwan, 407
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei City, Taiwan, 100
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan, 333
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Thammasat University Hospital
Pathumthani, Thailand, 12120
Songklanagarind Hospital
Songkhla, Thailand, 90110
Vietnam
Bach Mai Hospital
Hà Nội, Dong Da District, Vietnam
108 Military Central Hospital
Hà Nội, Hai Ba Trung District, Vietnam
Hue Central Hospital
Huế, Vin Ninh Ward, 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
Sponsors and Collaborators
Celsion
Investigators
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Study Chair: Ricardo Lencioni, MD University of Pisa
Study Chair: Ronnie Tung Ping Poon, MD Hong Kong University
Principal Investigator: Chen Min Hua, MD Beijing Cancer Hospital

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Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT02112656     History of Changes
Other Study ID Numbers: 104-13-302
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Keywords provided by Celsion:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action