A phase I/II trial of capecitabine combined with peginterferon α-2a in Patients with sorafenib-refractory advanced hepatocellular carcinoma

摘要: Background Several pilot studies have demonstrated the effectiveness of combination therapy with pyrimidine fluoride and interferon for advanced hepatocellular carcinoma.This study aimed to determine recommended dose capecitabine combined peginterferon α-2a (Phase I) evaluate its safety efficacy sorafenib-refractory carcinoma II). Methods Capecitabine was administered daily on days 1–14, while 1, 8, 15. The cycle repeated every 21 days. patients were scheduled receive [mg/(m2∙day)] (μg/week) at 3 levels in phase I: 1200 90 (level 1), 1600 2), 2000 3), respectively. Results A total 30 enrolled. level 3. Among 24 receiving drug dosage, 2 (8 %) exhibited a partial response, 9 (38 stable disease, 10 (42 progressive (13 not evaluated. median time progression overall survival 3.0 months 7.2 months, most common toxicities decreased white blood cell (88 %), neutrophil platelet counts (58 %); fatigue (50 palmar–plantar erythrodysesthesia syndrome %). Four (17 discontinued treatment because severe adverse events. Conclusion mg/(m2∙day) (90 μg/week) moderate, albeit manageable, toxicity declared as II dose. Further research is required refine this combination.