Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)

• Status: Terminated
• Trial end date: 2017-10-17
• Target enrollment: 0
• Participant gender: All

Summary

This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.

This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur; Clinique Saint Joseph, Liège; Erasme University Hospital; Jules Bordet Institute; University Hospital of Liege; University of Liege
• Treatments: Chlorotrianisene; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by:

• dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out

• histopathology

• satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable

• Hepatocellular carcinoma belonging to Barcelona Clinic Liver Cancer Stage System class B

• Tumor must be measurable on a multi-phase MRI according to mRECIST criteria

• Non-tumoral liver volume ≥ 800 cc

• Child-Pugh (CP) A to B7 cirrhosis

• HCC Patients can be included if they require treatment prior to liver transplantation

• ECOG performance status 0-1

• AST/ALT < 5 times ULN

• Initial platelets ≥ 50 000 x 10E9/l, neutrophils > 1500 x 10E9/l, Hb > 9 g/dl

• Serum creatinine < 1.5 X normal, or calculated Creatinine clearance rate ≥ 60 mL/min

• As tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. Cholangiocarcinoma cannot be included.

• Written informed consent form to be signed,

• Patient willing and able to comply to the follow-up schedule

• Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

• Eligibility for resection or ablative treatments

• Extra hepatic spread of the disease

• Previous treatment of the same lesion with TACE

• Previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen

• Uncontrolled Ascites

• Uncontrolled Encephalopathy

• Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required)

• Known current pregnancy

• Uncontrolled active co-morbidity