Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hepatocellular Carcinoma
Interventions:	Drug: ThermoDox; Drug: 5% Dextrose Solution

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
ThermoDox + RFA	ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes. ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Sham + RFA	Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes. 5% Dextrose Solution: Single 30 minute intravenous infusion

Participant Flow:   Overall Study

	ThermoDox + RFA	Sham + RFA
STARTED	354	347
COMPLETED	244	245
NOT COMPLETED	110	102

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ThermoDox + RFA	ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins. ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Sham + RFA	Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins. 5% Dextrose Solution: Single 30 minute intravenous infusion
Total	Total of all reporting groups

Baseline Measures

	ThermoDox + RFA	Sham + RFA	Total
Overall Participants Analyzed; [Units: Participants]	354	347	701
Age, Customized; [Units: Participants]
<40	7	10	17
40-<45	13	14	27
45-<50	18	25	43
50-<55	42	44	86
55-<60	57	50	107
60-<65	65	64	129
65-<70	44	45	89
70-<75	51	42	93
75-<80	33	34	67
80-<85	19	13	32
85+	2	4	6
Missing	3	2	5
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	87 24.6%	84 24.2%	171 24.4%
Male	267 75.4%	263 75.8%	530 75.6%
Race/Ethnicity, Customized; [Units: Participants]
Caucasian	42	26	68
Japanese	8	11	19
Korean	83	91	174
Taiwanese	66	62	128
Chinese	115	125	240
Other	40	32	72
Region of Enrollment; [Units: Participants]
United States	10	5	15
Philippines	18	21	39
Taiwan	68	63	131
Hong Kong	6	9	15
Canada	5	10	15
Thailand	16	8	24
Malaysia	7	6	13
Japan	8	10	18
Italy	32	17	49
China	104	104	208
Korea, Republic of	82	92	174

  Outcome Measures

1. Primary:

Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause [ Time Frame: 3 years ]

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2. Secondary:

Overall Survival as Measured by Time From Randomization to Death or the End of the Study. [ Time Frame: 3 years ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3. Secondary:

Time to Definite Worsening as Per Patient-Reported Outcomes [ Time Frame: 3 years ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4. Secondary:

Time to Local Recurrence. [ Time Frame: 3 years ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5. Secondary:

Safety [ Time Frame: 3 years ]

Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Nicholas Borys, M.D. Senior Vice President and Chief Medical Officer
Organization: Celsion Corporation
phone: 609-896-9100
e-mail: nborys@celsion.com

Responsible Party:	Celsion
ClinicalTrials.gov Identifier:	NCT00617981 History of Changes
Other Study ID Numbers:	104-06-301
First Submitted:	February 6, 2008
First Posted:	February 18, 2008
Results First Submitted:	February 3, 2017
Results First Posted:	March 24, 2017
Last Update Posted:	April 25, 2017