Clinical trial · Interventional
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD) Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
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 |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
| RAD001, sorafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1: RAD001 plus sorafenib
- interventionNames
- Drug: RAD001
- Drug: RAD001, sorafenib
Primary outcomes (2)
- measure
- Maximum tolerated dose of combination RAD001+sorafenib
- timeFrame
- Until maximum tolerated dose is determined
- measure
- Time to disease progression assessed when 60 events have been observed
- timeFrame
- Until number of events are reached
Secondary outcomes (9)
- measure
- Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced liver cancer * No previous systemic therapy for liver cancer * Measurable disease on CT or MRI * ECOG 1 or less * Child-Pugh A Exclusion Criteria: * Active bleeding during the last 30 days * Known history of HIV seropositivity * Any severe and/or uncontrolled medical conditions including Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available