Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)
- 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 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.
- 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 Bead™,
- Patients who are contraindicated for MRI