Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC

Hepatocellular Carcinoma Clinical Trial

— TRACER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379521
• Other study ID #: CRAD001OHK02
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2011
• Last updated: May 13, 2016
• Start date: June 2011
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHong Kong: Department of HealthKorea: Food and Drug AdministrationTaiwan: Department of HealthThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• everolimus

• everolimus placebo

Locations

Country	Name	City	State
Hong Kong	Novartis Investigative Site	Hong Kong
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Niaosong Township
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Muang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the anti-tumor effect, measured by Time to Progression (TTP), of everolimus (RAD001, Afinitor®) systemic treatment combined with local TACE procedure as compared to local TACE alone, based on the modified RECIST criteria		12 months	No
Secondary	the benefit of the combination strategy as measured by the overall response rate (ORR) and disease control rate (DCR), based on the modified RECIST criteria		12 months	No
Secondary	the differences between the two treatment groups in TTP, ORR and DCR rate, based on the original RECIST criteria		12 months	No
Secondary	the benefit of the combination strategy as measured by overall survival (OS)		24 months	No
Secondary	the difference between the two treatment groups in incidences of cumulative new nodular recurrence, portal vein invasion and extrahepatic metastases		12 months	No
Secondary	Adverse events (AEs) as determined by CTCAE version 4.02, serious adverse events (SAEs), discontinuation rate and tolerability of the combination strategy		12 months	Yes