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

Phase 2
18 Years
Not Enrolling
Primary Liver Cancer

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Trial Information

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

Inclusion Criteria

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

- 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

- 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

- 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 Beadâ„¢,

- Patients who are contraindicated for MRI

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Objective response rate measured according to RECIST and EASL

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Prof Johannes Lammer

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Allgemines Krankenhaus, Vienna, 1090, Austria


Austria: Federal Ministry for Social Security and Generations, Vienna, Austria

Study ID:




Start Date:

November 2005

Completion Date:

January 2008

Related Keywords:

  • Primary Liver Cancer
  • Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular