Spots Global Cancer Trial Database for Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)

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Trial Identification

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

Official Title: Randomized Controlled Phase II Trial Comparing Trans-Arterial Chemo-Embolization (TACE) With TACE Plus Stereotactic Ablative Radiotherapy (SABR) in Stage BCLC B Hepatocarcinoma (HepSTAR)

Study ID: NCT02958163

Conditions

Liver Neoplasms

Hepatocellular Cancer

Interventions

Trans-arterial Chemo-Embolization

Doxorubicin

Stereotactic Ablative Radiotherapy

Study Description

Brief 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.

Detailed 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