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Background  In Japan, transarterial infusion chemotherapy using cisplatin (CDDP-TAI) is frequently used for advanced hepatocellular carcinoma (HCC). Moreover, oral chemotherapy with S-1, an oral fluoropyrimidine derivative, has also elicited promising responses in HCC patients. We determined the recommended dosage for CDDP-TAI plus S-1 combination therapy for advanced HCC.    Methods  Twelve Child–Pugh class A or B patients with advanced HCC who met the eligibility criteria were enrolled in this phase I trial. Patients received CDDP-TAI (infusion, day 1) plus S-1 (oral administration, days 1–21) every 5 weeks until disease progression.    Results  Cisplatin (65 mg/m 2 ) was administered with S-1 at 50 mg · m -2  day -1  (level 1, 3 patients), 60 mg · m -2  day -1  (level 2, 3 patients), or 80 mg · m -2  day -1  (level 3, 6 patients). The total number of treatment courses was 25 (median, 2 courses/patient; range, 1–6 courses). Dose-limiting toxicity was not observed in any patient at any level; therefore, the recommended dosage for cisplatin and S-1 in combination was level 3. Grade 3 adverse events were elevated alanine aminotransferase levels (2 patients), elevated aspartate aminotransferase levels (2 patients), anemia (1 patient), and decreased platelet counts (1 patient). Median progression-free survival and overall survival were 73 days and 328 days, respectively. The disease control rate was 58% (7/12); 17% (2/12) of patients achieved partial response and 42% (5/12) achieved stable disease. CDDP-TAI plus S-1 is safe for the treatment of HCC.    Conclusion  The recommended dosage for further evaluation of this combination therapy in phase II studies is 65 mg/m 2  CDDP and 80 mg/m 2  S-1.    Trial registration  UMIN; number:  UMIN3113

Transarterial infusion chemotherapy with cisplatin plus S-1 for hepatocellular carcinoma treatment: a phase I trial