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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Terminated; Phase 2

Conditions: Liver Neoplasms; Hepatocellular Cancer

Treatments: Drug: Doxorubicin; Radiation: Stereotactic Ablative Radiotherapy; Procedure: Trans-arterial Chemo-Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02958163

28248368

Details and patient eligibility

About

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.

Full description

The patients will be randomized in 2 arms determining the treatment they will receive:

Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Trans-Arterial Chemo-embolization (TACE)

Active Comparator group

Description:

Trans-arterial Embolisation will be performed with drug-eluting beads loaded with Doxorubicin. First session will be given within 4 weeks after randomization. 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last session of TACE corresponds to the treatment completion date.

Treatment:

Procedure: Trans-arterial Chemo-Embolization

Drug: Doxorubicin

TACE+Stereotactic Ablative Radiotherapy

Experimental group

Description:

The first part of the treatment, which is the DEB-TACE delivery, will be exactly the same than in arm A. The radiotherapy (SABR) will then start within 4 to 6 weeks after. Afterwards, 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last SABR fraction or the last session of TACE corresponds to the treatment completion date.

Treatment:

Procedure: Trans-arterial Chemo-Embolization

Radiation: Stereotactic Ablative Radiotherapy

Drug: Doxorubicin