Clinical trial · Interventional
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
- 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)
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
- description
- Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- Drug: Erlotinib (Tarceva)
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib (Nexavar, BAY43-9006) + Placebo
- description
- Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- Drug: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years of age * Patients who have a life expectancy of at least 12 weeks * Patients with histological or cytologically documented HCC * Patients must have at least one tumor lesion that meets both of the following criteria: * The lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (RECIST) * The lesion has not been previously treated with local therapy * Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1 * Cirrhotic status of Child-Pugh class A. * Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time. Exclusion Criteria: * History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted. * Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test). * History of interstitial lung disease (ILD). * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Previous treatment with yttrium-90 spheres * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
References
Publications (0)
Data not yet available