A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma (SOCRATES HCC)

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2024年7月8日

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Alan Wigg,
Jonathan Tibballs,
Richard Woodman,
Katherine Stuart,
Hien Le,
Stuart K. Roberts,
John K. Olynyk,
Simone I. Strasser,
Michael Wallace,
Jarad Martin,
Annette Haworth,
Nicholas Hardcastle,
Kee Fong Loo,
Colin Tang,
Yoo Young Lee,
Julie Chu,
Richard De Abreu Lourenco,
Adam Koukourou,
Diederick De Boo,
Kate McLean,
Jackie Buck,
Rohit Sawhney,
Amanda Nicoll,
Anouk Dev,
Marnie Wood,
Alicia Braund,
Martin Weltman,
Richard Khor,
Miriam Levy,
Tim Wang,
Michael Potter,
James Haridy,
Ashok Raj,
Oliver Duncan,
Amany Zekry,
Natalie Collier,
James O’Beirne,
Catherine Holliday,
Yuvnik Trada,
Jaw Tronidjaja,
Jacob George,
David Pryor

摘要

Background

Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking.

Methods

Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses.

Discussion

The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research.

Trial registration

anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.