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

• Published in: BMC cancer Vol. 24; no. 1; pp. 813 - 9
• Main Authors: Wigg, Alan, Tibballs, Jonathan, Woodman, Richard, Stuart, Katherine, Le, Hien, Roberts, Stuart K, Olynyk, John K, Strasser, Simone I, Wallace, Michael, Martin, Jarad, Haworth, Annette, Hardcastle, Nicholas, Loo, Kee Fong, Tang, Colin, Lee, Yoo Young, Chu, Julie, De Abreu Lourenco, Richard, Koukourou, Adam, De Boo, Diederick, McLean, Kate, Buck, Jackie, Sawhney, Rohit, Nicoll, Amanda, Dev, Anouk, Wood, Marnie, Braund, Alicia, Weltman, Martin, Khor, Richard, Levy, Miriam, Wang, Tim, Potter, Michael, Haridy, James, Raj, Ashok, Duncan, Oliver, Zekry, Amany, Collier, Natalie, O'Beirne, James, Holliday, Catherine, Trada, Yuvnik, Tronidjaja, Jaw, George, Jacob, Pryor, David
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08-07-2024; BioMed Central; BMC
• Subjects: Ablation; Ablation (Surgery); Adult; Aged; Ascites; Cancer therapies; Carcinoma, Hepatocellular - pathology; Carcinoma, Hepatocellular - radiotherapy; Carcinoma, Hepatocellular - surgery; Carcinoma, Hepatocellular - therapy; Care and treatment; Comorbidity; Diagnosis; Early-stage hepatocellular carcinoma; Female; Hepatocellular carcinoma; Hepatoma; Humans; Liver; Liver cancer; Liver diseases; Liver Neoplasms - pathology; Liver Neoplasms - radiotherapy; Liver Neoplasms - surgery; Liver Neoplasms - therapy; Liver transplants; Male; Middle Aged; Neoplasm Staging; Oncology; Patient outcomes; Patients; Prospective Studies; Radiation therapy; Radiosurgery - methods; Radiotherapy; Randomized Controlled Trials as Topic; SABR; SBRT; Skin cancer; Standard of Care; Stereotactic ablative radiotherapy; Study Protocol; Survival; Thermal ablation; Toxicity; Transarterial therapies; Transplantation; Tumors; Australia; Transarterial therapies; Stereotactic ablative radiotherapy; SBRT; SABR; Thermal ablation; Early-stage hepatocellular carcinoma; Treatment stage migration
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-024-12504-2

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