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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001OHK02

NCT ID:

NCT01379521

Start Date:

June 2011

Completion Date:

August 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Localised
  • unresectable
  • chemoembolization
  • Carcinoma
  • Carcinoma, Hepatocellular

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