Clinical trial · Interventional
Epirubicin and Thalidomide in Treating Patients With Liver Cancer
A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic 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)
RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Antitumor activity
- measure
- Toxic effects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma * Locally unresectable or metastatic disease * Measurable disease * No clinically apparent CNS metastases * No carcinomatous meningitis PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * SGOT no greater than 5 times upper limit of normal * Bilirubin no greater than 3.0 mg/dL * INR no greater than 1.5\* * Albumin at least 2.0 g/dL NOTE: \*Not required for patients receiving full anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * LVEF normal by echocardiogram or MUGA Other * Not pregnant or nursing * Fertile patients must use effective contraception * Willing and able to participate in the System for Thalidomide Education and Prescribing Safety (STEPS) program * No uncontrolled serious medical or psychiatric illness * No other concurrent uncontrolled malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 1 prior chemotherapy regimen for hepatocellular carcinoma * No prior chemoembolization to the liver Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 2 weeks since prior major surgery
References
Publications (1)
- RESULTZhu AX, Fuchs CS, Clark JW, Muzikansky A, Taylor K, Sheehan S, Tam K, Yung E, Kulke MH, Ryan DP. A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma. Oncologist. 2005 Jun-Jul;10(6):392-8. doi: 10.1634/theoncologist.10-6-392. PMID 15967833