Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC

NCT ID: NCT01379521

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-06-30

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).

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

everolimus + TACE

everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)

Group Type: EXPERIMENTAL

everolimus

Intervention Type: DRUG

placebo + TACE

Placebo by mouth + transcatheter arterial chemoembolization (TACE)

Group Type: PLACEBO_COMPARATOR

everolimus placebo

Intervention Type: DRUG

Interventions

everolimus

Intervention Type: DRUG

everolimus placebo

Intervention Type: DRUG

Other Intervention Names

RAD001; Afinitor®)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Hong Kong, , Hong Kong

Novartis Investigative Site

Kaohsiung, Taiwan, Taiwan

Novartis Investigative Site

Kaohsiung City, , Taiwan

Novartis Investigative Site

Linkou District, , Taiwan

Novartis Investigative Site

Chiang Mai, , Thailand

Countries

Hong Kong; Taiwan; Thailand

Other Identifiers

CRAD001OHK02

Identifier Type: -

Identifier Source: org_study_id