Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)

Summary

The goal of this clinical trial is to compare the safety and efficacy of sequential Transarterial Chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) versus Y90-radioembolisation (SIRT), followed by systemic therapy in patients with large, locally advanced, unresectable Hepatocellular carcinoma (HCC). The main question it aims to answer is whether Sequential TACE-SBRT potentially gives longer Progression-free survival (PFS) benefit with similar toxicities as compared with Y90 SIRT. Participants will be recruited via multidisciplinary meetings (MDTs) with hepatobiliary surgeons, medical hepatologists and radiologists with consistent, strict considerations on eligibility and treatment alternatives. Eligible patients will be randomized in 1:1 ratio to received one of the two treatment arms.

Timeline

Start

2024-04-01

Primary completion

2034-03-31

Completion

2034-12-31

Publications

• Background Wong N, Chiang C, Ho C, Yip W, Yeung C, Chan M, et al. Prognostic Factors and Survival in Advanced Large Hepatocellular Carcinomas Treated with Combined Transarterial Chemoembolisation and Hypofractionated Image-guided Radiotherapy. Hong Kong Journal of Radiology. 2020 Sep 25;23(3):198-207.
• Background Chiang CL, Chan KSK, Chiu KWH, Lee FAS, Chen W, Wong NSM, Ho RLM, Lee VWY, Man K, Kong FMS, Chan ACY. Complete Response to Locoregional Therapy Plus Immunotherapy for Hepatocellular Carcinoma. JAMA Oncol. 2024 Nov 1;10(11):1548-1553. doi: 10.1001/jamaoncol.2024.4085.
• Background Chiang CL, Lee FAS, Chan KSK, Lee VWY, Chiu KWH, Ho RLM, Fong JKS, Wong NSM, Yip WWL, Yeung CSY, Lau VWH, Man K, Kong FMS, Chan ACY. Survival Outcome Analysis of Stereotactic Body Radiotherapy and Immunotherapy (SBRT-IO) versus SBRT-Alone in Unresectable Hepatocellular Carcinoma. Liver Cancer. 2023 Oct 1;13(3):265-276. doi: 10.1159/000533425. eCollection 2024 Jun.
• Background Chiang CL, Chiu KWH, Chan KSK, Lee FAS, Li JCB, Wan CWS, Dai WC, Lam TC, Chen W, Wong NSM, Cheung ALY, Lee VWY, Lau VWH, El Helali A, Man K, Kong FMS, Lo CM, Chan AC. Sequential transarterial chemoembolisation and stereotactic body radiotherapy followed by immunotherapy as conversion therapy for patients with locally advanced, unresectable hepatocellular carcinoma (START-FIT): a single-arm, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):169-178. doi: 10.1016/S2468-1253(22)00339-9. Epub 2022 Dec 15.
• Background de la Torre-Alaez M, Matilla A, Varela M, Inarrairaegui M, Reig M, Lledo JL, Arenas JI, Lorente S, Testillano M, Marquez L, Da Fonseca L, Argemi J, Gomez-Martin C, Rodriguez-Fraile M, Bilbao JI, Sangro B. Nivolumab after selective internal radiation therapy for the treatment of hepatocellular carcinoma: a phase 2, single-arm study. J Immunother Cancer. 2022 Nov;10(11):e005457. doi: 10.1136/jitc-2022-005457.
• Background Dawson LA, Winter K, Knox J, Zhu AX, Krishnan S, Guha C, et al. NRG/RTOG 1112: Randomized Phase III Study of Sorafenib vs. Stereotactic Body Radiation Therapy (SBRT) Followed by Sorafenib in Hepatocellular Carcinoma (HCC) (NCT01730937). Int J Radiat Oncol. 2022 Dec;114(5):1057.
• Background Apisarnthanarax S, Barry A, Cao M, Czito B, DeMatteo R, Drinane M, Hallemeier CL, Koay EJ, Lasley F, Meyer J, Owen D, Pursley J, Schaub SK, Smith G, Venepalli NK, Zibari G, Cardenes H. External Beam Radiation Therapy for Primary Liver Cancers: An ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2022 Jan-Feb;12(1):28-51. doi: 10.1016/j.prro.2021.09.004. Epub 2021 Oct 21.
• Background Wong SS, Wong WH, Ngar DY, Ma VW, Cheung C, Lee FA. NTWC Guideline for Transarterial Radioembolization using Yttrium-90 Microspheres (Y90-TARE). Hong Kong; 2020 Sep. (1).
• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

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