Clinical trial · Interventional
Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to low enrollment. This resulted in the study being underpowered and inconclusive.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
| everolimus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- everolimus + TACE
- description
- everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
- interventionNames
- Drug: everolimus
- type
- PLACEBO_COMPARATOR
- label
- placebo + TACE
- description
- Placebo by mouth + transcatheter arterial chemoembolization (TACE)
- interventionNames
- Drug: everolimus placebo
Primary outcomes (1)
- measure
- Time to Progression (TTP) Based on the Modified RECIST Criteria
- timeFrame
- 3, 6, 12, 18 and 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available