Sep 30

SS 36 - GI 3: Liver - Checking in on Inhibitors, inSPECTing Liver Function, and Making Progress Oligo-ly

309 - Efficacy and Safety of Camrelizumab and Apatinib in Combination with IMRT in Unresectable Hepatocellular Carcinoma: A Non-Randomised Phase 2 Study

01:15pm - 01:25pm PT

Room 22/23

Presenter(s)

Hong-zhi Wang, MD - Peking University Cancer Hospital and Institute, Beijing, Beijing

H. Z. Wang¹, K. Wang², X. Zheng¹, D. Z. Dong¹, X. G. Zhu¹, B. C. Xing², and W. H. Wang¹; ¹Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China, ²Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Hepatopancreatobiliary Surgery Unit I, Peking University Cancer Hospital & Institute, Beijing, China

Purpose/Objective(s):

This study aimed to assess the efficacy and safety of combining Camrelizumab (an anti-programmed death 1 antibody) and Apatinib (a tyrosine kinase inhibitor) with intensity-modulated radiotherapy (IMRT) in patients with unresectable hepatocellular carcinoma (HCC).

Materials/Methods:

This non-randomized phase 2 study enrolled patients with unresectable HCC who were either systemic treatment-naïve or refractory/intolerant to first-line targeted therapy. The enrolled patients received IMRT at a dose of 50-60 Gy in 25-30 fractions, with the target volume encompassing all visible lesions. Patients were administered Camrelizumab intravenously at a dose of 200 mg every 3 weeks and Apatinib orally a dose of 250 mg once daily during IMRT, continuing for 2 years or until unacceptable toxicity or disease progression. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), local failure rate, overall survival (OS) and adverse events.

Results:

From October 2020 to November 2024, 44 patients were included in this study (40 men and 4 women; median age, 57 years [range, 39-77 years]). Among them, 40 patients were diagnosed with BCLC stage C (90.9%). The median number of intrahepatic lesions was one (range, 1-5), with a median intrahepatic tumor diameter of 6.0 cm (range, 1.9-16.0 cm). Tumor thrombus was observed in 30 cases (68.2%), and lymph node metastases was found in 11 cases (25.0%). The ORR based on RECIST 1.1 and modified RECIST criteria were 77.3% and 84.1%, respectively, with a complete response (CR) rate of 11.4% and 54.5%, respectively. The median follow-up time was 27.7 months. The cumulative rate of local failure at 2 years was 8.0%. The median PFS was 13.8 months, and the PFS rate at 2 years was 40.0%. The median OS was not reached, and OS rate at 2 years was 63.5%. According to CTCAE 5.0, grade 3-4 treatment-related adverse events were observed in 35 patients (79.5%), with the most common being thrombocytopenia (38.6%), leukopenia (29.5%) and hypertension (29.5%). No treatment-related deaths occurred.

Conclusion:

The combination of systematic therapies involving Camrelizumab and Apatinib with local-regional treatment of IMRT showed promising outcomes and manageable toxicities in patients with unresectable HCC. These findings warrant to be confirmed in phase 3 prospective studies.