Abstract 724P
Background
There is no globally recognized standard adjuvant therapy for HCC after radical resection. Herein, we explored to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210 combined with apatinib as adjuvant treatment versus hepatic arterial infusion (HAI) in HCC patients with high risk of recurrence after radical resection.
Methods
This was an ongoing multicenter, randomized, controlled phase II trial. All HCC patients were Child-Pugh Class A, confirmed as high risk of recurrence such as portal vein tumor thrombus (PVTT) involved in second-order branch or above, microvascular invasion (MVI)，microsatellite leisions and largest tumor diameter > 5 cm. Eligible patients were randomly assigned (1:1) to receive SHR-1210 (200mg, q2w) and apatinib (250mg, q.d.) for 12 cycles, or twice standard HAI treatments (epirubicin 80-100 mg or epirubicin 50mg + oxaliplatin 50mg). The primary endpoint was recurrence-free survival (RFS).
Results
At date cut off (Mar 04, 2022), 82 HCC patients (pts) (41pts in SHR-1210-apatinib) had been recruited. Full analysis (FAS) population contained 73 pts and intention to treat (ITT) population included 82 pts. The hazard ratio for relapse or death with SHR-1210-apatinib as compared with HAI was 0.72 (95% CI 0.30-1.71) and 0.62 (95% CI 0.27-1.42) in FAS and ITT population, respectively. mRFS with SHR-1210-apatinib vs HAI group was 22.7 months vs 16.4 months and 22.7 months vs 14.9 months in FAS and ITT population. mRFS in pts with MVI was 22.7 months with SHR-1210-apatinib and 14.9 months with HAI group in both FAS ( HR 0.65;95% CI 0.27,1.55) and ITT population (HR 0.57;95% CI 0.25,1.30). The most common grade 3 or 4 adverse events in SHR-1210-Apatinib were alanine and aspartate aminotransferase increase (13.16%), Thrombocytopenia（10.53%）, neutrophil count decrease（7.89%）, γ-glutamyltransferase (GGT) increase (5.26%), leukopenia (5.26%).
Conclusions
SHR-1210-apatinib had an acceptable safety profile and encouraging preliminary efficacy, offering a promising treatment option superior to HAI for adjuvant therapy in HCC, especially for pts with MVI.
Clinical trial identification
NCT03839550.
Editorial acknowledgement
Legal entity responsible for the study
National Cancer Center/Cancer Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.