Clinical trial NCT01379521: Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Localised
unresectable
chemoembolization
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Time to Progression (TTP) Based on the Modified RECIST Criteria
timeFrame: 3, 6, 12, 18 and 24 months
Secondary outcomes:
measure: Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST
timeFrame: 6, 12 months, end of study
measure: Time to Progression Based on Original RECIST
timeFrame: 6, 12 months, end of study
measure: Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST
timeFrame: 6, 12 months, end of study
measure: Overall Survival (OS)
timeFrame: 6, 12, 18, 24, 30 months
measure: Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases
timeFrame: 30 months
measure: Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months
timeFrame: baseline, 30 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: