Data from Efficacy and safety of stereotactic body radiotherapy combined with Camrelizumab and Apatinib in hepatocellular carcinoma patients with portal vein tumor thrombus

AbstractPurpose: This study aimed to evaluate the efficacy and safety of camrelizumab plus apatinib with or without stereotactic body radiotherapy (SBRT) as first-line therapy for hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT). Patients and Methods: This is a multicenter, open-label, non-comparative, randomized trial that recruited HCC patients with type II/III/IV PVTT, who had not previously received systemic therapy. Patients were randomly assigned (2:1) to receive camrelizumab (200 mg, Q3W) and apatinib (250 mg, QD) with or without SBRT (95% PTV, 36 - 40 Gy/6 - 8 Gy). The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to progression (TTP) and safety. Results: Sixty patients were enrolled and randomly assigned to two prospective cohorts. Median OS were 12.7 months (95% CI, 10.2-NA) and 8.6 months (95% CI, 5.6-NA), and median PFS were 4.6 months (95% CI, 3.3-7.0) and 2.5 months (95% CI, 2.0-7.6) for the SBRT and non-SBRT cohorts, respectively. The ORR and DCR were 47.5% and 72.5% in the SBRT cohort, and 20.0% and 40.0% in the non-SBRT cohort. The most common treatment-related adverse events of any grade were hypertension (55.0%), hand-foot syndrome (51.7%), and leukopenia (50.0%). Grade ≥ 3 was reported in 13 (21.7%) patients. Conclusion: First-line treatment with camrelizumab-apatinib combined with or without SBRT showed clinical benefits in HCC patients with PVTT, with an acceptable safety profile. Thus, these combination regimens may be potential options for such patients.