Clinical trial · Interventional
Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, 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)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma (liver cancer). PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery.
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 |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| hepatic artery embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (6)
- measure
- Overall response
- measure
- Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks
- measure
- Time to progression as assessed by RECIST criteria
- measure
- Toxicity
- measure
- Health economics
- measure
- Proteomic and immunological analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma (HCC) * Advanced, unresectable disease * No clinically significant ascites * No modified Child-Pugh class C liver disease * No main portal vein occlusion/involvement * No extrahepatic tumor of any kind PATIENT CHARACTERISTICS: Age * 18 and over (16 and over for patients residing in Scotland) Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.5 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 5.0 mg/dL * Transaminases \< 2.5 times upper limit of normal (ULN) * INR \< 1.5 Renal * Creatinine \< 2 times ULN Cardiovascular * No New York Heart Association class III or IV cardiac disease * No acute angina * No significant peripheral vascular disease * No thrombosis of main portal vein * LVEF ≥ 50% Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other concurrent serious medical condition * No serious infection * No psychological, familial, sociological, or geographical factors that would preclude study compliance * No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for advanced unresectable HCC Chemotherapy * No prior systemic or regional chemotherapy * No prior chemotherapy for advanced unresectable HCC * No other concurrent anticancer chemotherapy Endocrine therapy * No prior hormonal therapy for advanced unresectable HCC Radiotherapy * No prior radiotherapy for advanced unresectable HCC * No other concurrent anticancer radiotherapy Surgery * More than 7 days since prior major surgery * More than 3 days since prior laparoscopy Other * More than 4 weeks since prior investigational agents * More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease * No other concurrent investigational agents
References
Publications (0)
Data not yet available