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Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC (TRACER)

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ClinicalTrials.gov Identifier: NCT01379521
Recruitment Status : Terminated (The study was terminated due to low enrollment. This resulted in the study being underpowered and inconclusive.)
First Posted : June 23, 2011
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: everolimus Drug: everolimus placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-blinded, Multicenter Asian Study Investigating the Combination of Transcatheter Arterial Chemoembolization (TACE) and Oral Everolimus (RAD001, Afinitor®) in Localised Unresectable Hepatocellular Carcinoma (HCC) - The TRACER Study
Study Start Date : June 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: everolimus + TACE
everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
Drug: everolimus
Other Names:
  • RAD001
  • Afinitor®)

Placebo Comparator: placebo + TACE
Placebo by mouth + transcatheter arterial chemoembolization (TACE)
Drug: everolimus placebo



Primary Outcome Measures :
  1. Time to Progression (TTP) Based on the Modified RECIST Criteria [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of "viable" target lesion (arterial phase enhancement)


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST [ Time Frame: 6, 12 months, end of study ]
    Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the modified RECIST. Complete response: Disappearance of arterial phase enhance-ment in all target lesions. Partial response: >30% decrease in sum of the longest diameters (SLD) of "viable" target lesion (arterial phase enhance-ment)Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.

  2. Time to Progression Based on Original RECIST [ Time Frame: 6, 12 months, end of study ]
    Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on original RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of target lesions with an absolute increase of ≥5 mm; new lesions. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.

  3. Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST [ Time Frame: 6, 12 months, end of study ]
    Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the Complete response: Disappearance of all target lesions or lymph nodes <10 mm in the short axis Partial response: >30% decrease in sum of the longest diameters (SLD) of target lesions Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.

  4. Overall Survival (OS) [ Time Frame: 6, 12, 18, 24, 30 months ]
    Overall survival was defined as the time from date of randomization to date of death due to any cause. If death had not occurred at the date of the analysis cut-off then OS was censored at the date of the last contact.

  5. Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases [ Time Frame: 30 months ]
    Incidences of cumulative new nodular recurrence, portal vein invasion and extra hepatic metastases but incidence of portal vein invasion meant those patients without documented vascular invasion at screening/baseline. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.

  6. Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months [ Time Frame: baseline, 30 months ]
    Percentage of participants with a decrease in the sum of the of longest diameters (SLD) of target lesions from Baseline to 30 months



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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:

  • Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
  • Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
  • At least one nodule between > 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
  • Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
  • ECOG performance status < 2cm
  • Cirrhotic status of Child-Pugh class A or early B
  • HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug

Exclusion Criteria:

  • Any local and/or investigational drugs within 28 days prior to randomization
  • Active bleeding during the last 28 days prior to screening including variceal bleeding
  • Prior therapy with mTOR inhibitors
  • Tumor burden of > 60% liver involvement
  • Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
  • Failed first TACE at Day 0, Cycle 1 for any reason
  • Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
  • Alcohol intake of 80 grams per day
  • Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT01379521


Locations
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan, 807
Novartis Investigative Site
Kaohsiung, Taiwan, 83301
Novartis Investigative Site
Lin-Kou, Taiwan, 33305
Thailand
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01379521     History of Changes
Other Study ID Numbers: CRAD001OHK02
First Posted: June 23, 2011    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017
Last Verified: April 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Localised
unresectable
chemoembolization

Additional relevant MeSH terms:
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
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents