Dose Escalation STRATegy of Regorafenib in Advanced HepatoCellular Carcinoma: Phase II STRATA-HCC Trial

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All articles of this category (opens in new window) Address for correspondence Leonardo Gomes Da Fonseca (l.fonseca@fm.usp.br) Introduction: Regorafenib prolonged overall survival (OS) after progression on sorafenib in the phase 3 RESOURCE trial with the standard-dose strategy (160 mg/day orally for 21 days of a 28-day cycle). In the RESOURCE study, the median treatment duration was 3.6 months, and 25% of patients were discontinued due to treatment-related adverse events. Despite limited supportive evidence, various dosing schedules are used to alleviate toxicities. Aim: This trial aims to evaluate the safety and activity of an escalated regorafenib dosing schedule. Methods: STRATA-HCC is a phase II single-arm study that included previously treated HCC patients with Child-Pugh A-B7 and PS 0-1. Regorafenib was given in a dose-escalation strategy starting 80 mg/d with weekly escalation, per 40 mg increments, to 160 mg/d if no significant drug-related adverse events occurred during cycles 1-2. The maximum tolerated dose (MTD) was administered from cycle 3 on. The primary endpoint was the proportion of patients completing cycle 4 with no progression or intolerance. OS, response rate, and quality of life are secondary endpoints. The primary endpoint was achieved if 65% of patients completed cycle 4 (p = 0.10, β = 20%). Results: 25 patients were included (median age 64 yrs, 80% viral etiology, 80% prior locoregional therapies). Eight (32%) patients had received prior immunotherapy, and 20% had received ≥2 lines of systemic treatment. Most were BCLC-C (72%), performance status 1 (56%), and Child-Pugh A (92%). The primary endpoint was met, with 72% of participants completing 4 cycles (8% did not complete due to intolerance, and 20% due to disease progression). MTD was 120 mg/d in 52% and 80 mg/d in 44%. Most common grade ≥2 events were fatigue (20%), hand-foot skin reaction (12%), and hypertension (12%). The 1-year survival rate for patients treated with regorafenib in the 2nd line (n=20) was 66.9% (95%CI: 32.4-86.7%) with the median OS not reached. The median OS of the entire cohort was 9.9 months (95%CI: 6.9-NA). Disease control was achieved in 88%. Conclusion: This single-arm trial demonstrated that a dose-escalation strategy of regorafenib provided treatment benefits with a favorable safety profile, representing an alternative approach after 1st-line therapy. Clinical trial information : NCT05622136. Publication History Article published online: 26 June 2026 © 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/) Thieme Revinter Publicações Ltda. Rua Rego Freitas, 175, loja 1, República, São Paulo, SP, CEP 01220-010, Brazil Bibliographical Record Leonardo Gomes Da Fonseca, Murilo Cazellato Pacheco Mello, Liege Tambellini Gomes, Joao Vitor Antunes Gregorio, Giovanni Mendonça Bariani, Erika Pereira Brandao, Heloisa De Souza Pereira, Juliana Mariano de Lima, Fernanda Jatobá Souza, Marta Viviane Leite Machado, Flávia Cavalcante Carvalho, Paulo Marcelo Hoff, Jorge Sabbaga. Dose Escalation STRATegy of Regorafenib in Advanced HepatoCellular Carcinoma: Phase II STRATA-HCC Trial. Brazilian Journal of Oncology 2026; 22. DOI: 10.1055/s-0046-1825483

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