P-354 A single arm phase II trial of capecitabine and erlotinib in patients with advanced hepatocellular carcinoma after first-line failure (CAPER- HCC study)

Low dose capecitabine in combination with erlotinib has potential anti-tumor activity limited toxicity, a cost-effective option for advanced hepatocellular carcinoma (HCC). Current second-line systemic therapies are of reach lower-middle-income countries (LMIC). Patients more than 17 years old having ECOG PS 0-2, (BCLC B or C) HCC failing (progressed intolerant to) first-line therapy, were enrolled phase 2 single-arm study. Erlotinib 100mg once day and 500mg twice till progressive disease intolerable side effects administered. The primary endpoint was to achieve 30 % Progression-free survival (PFS) at 6 months the compared 10% historical cohort. Secondary objectives include Overall (OS), safety, Response rate (RR). Fifteen patients received least one month study medications. median age 62 14 (93.3%) males. Hepatitis most common cause (40%). Child-Pugh score 5 (range; 5-7) BCLC stage C all time enrolment. One patient (16.67%) achieved stabilization. For 15 enrolled, PFS 2.0 (95% CI 1.25- 2.74) OS 3.0 1.95- 4.0) progression-free less months. Due poor efficacy futility analysis, stopped further enrollment. regimen well tolerated grade 3 diarrhea induced rash 1 each, while fatigue seen (13.3%) consequent modification/ interruptions requirement (20%) patients. but did not preplanned criteria survival. Future studies evaluating this may consider using different dosing strategies.