Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma

Official Title
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Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

Conditions
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Primary Liver Cancer

Intervention / Treatment
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* Device: Transarterialchemoembolisation (TACE)
* Device: DC Bead with Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, see appendix 4 and staged according to the BCLC criteria. Patient chooses to participate and has signed the informed consent document Age above 18 years old Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure 2. Patient is eligible for resection or percutaneous ablation but the treatment is unfeasible or the patient has declined. This decision must be documented in the patient's records. Patient is eligible for chemoembolisation prior to transplantation and the expected transplant waiting time exceeds 6 months. Patients who demonstrates recurrence following potentially curative treatment (resection and percutaneous ablation) who have clearly measurable disease according to RECIST or EASL Patients with Performance Status ECOG 0 and 1 Patients with well preserved liver function (Child-Pugh A and B) Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks. Exclusion criteria Patients with another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia Patients previously treated with transarterial embolisation (with or without chemotherapy). Patients previously treated with anthracyclines (ie doxorubicin). Patients' whose only measurable disease is within an area of the liver previously subjected to radiotherapy. Advanced liver disease: Child-Pugh C, active gastrointestinal bleeding, encephalopathy or clinically relevant ascites. Bilirubin levels >3mg/dl Advanced tumoural disease: BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or BCLC class D (WHO performance status 3 or 4, Okuda III stage) or Diffuse HCC defined as >50% tumour involvement of the whole liver Any contraindication for doxorubicin administration: serum bilirubin >5mg/dL, WBC <3000 cells/mm3 neutrophil <1500 cells/mm3, cardiac ejection fraction <50 percent assessed by isotopic ventriculography, echocardiography or MRI Any contraindication for hepatic embolisation procedures: porto-systemic shunt, hepatofugal blood flow; impaired clotting tests (platelet count <50000/mm3, prothrombin activity <50 percent), renal insufficiency/failure, serum creatinine > 2mg/dl (177umol/l) severe atheromatosis, AST and/or ALT >5x ULN or, when greater >250U/l Women who are pregnant or breast feeding Allergy to contrast media Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk, that would preclude the safe use of DC Bead™, or TACE Patients who are contraindicated for MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transarterialchemoembolisation (TACE)<br>Conventional TACE with doxorubicin | Device: Transarterialchemoembolisation (TACE)<br> <br> * Other names: Conventional TACE with doxorubicin;|
| Other: DC Bead<br>DC Bead with doxorubicin | Device: DC Bead with Doxorubicin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate measured according to RECIST and EASL |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 6 month | 
| Change in Alpha Fetal Protein (AFP) over time |  | 6 months | 
| Time to hospital discharge |  | 6 months | 
| Safety |  | 6 months | 
| Other procedures or interventions required |  | 6 months | 
| Cardiotoxicity |  | 6 months | 
| Local Tumour Response |  | 6 months | 
| Health care resource use |  | 6 months | 
| Patient quality of life |  | 6 months | 
| Time To Progression |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma (HCC)