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The combination of camrelizumab, apatinib, and hepatic arterial infusion chemotherapy (HAIC) demonstrated “encouraging” results in patients with advanced hepatocellular carcinoma (HCC) in a phase 2 trial, according to researchers.
The combination produced a high response rate, and toxicities were considered manageable. The researchers reported these results in Signal Transduction and Targeted Therapy.
The trial, TRIPLET (ClinicalTrials.gov Identifier: NCT04191889), enrolled 35 patients with Barcelona Clinical Liver Cancer (BCLC) stage C HCC.
The patients’ median age was 46 (range, 27-67) years, and 91.4% were men. All patients had hepatitis B, 60.0% had tumors measuring 10 cm or larger, and 14.3% had extrahepatic metastasis.
The patients received up to 6 cycles of HAIC (oxaliplatin, leucovorin, and fluorouracil). They also received camrelizumab and apatinib until disease progression or unacceptable toxicity.
At a median follow-up of 23.1 months, patients had received a median of 6 cycles of HAIC and a median of 9 cycles of camrelizumab. They had received apatinib for a median of 9.1 months.
The objective response rate was 77.1% per RECIST version 1.1 criteria. There were no complete responses, but 27 patients had a partial response, and 7 patients had stable disease.
The objective response rate per modified RECIST criteria was 88.6%. This included 4 complete responses and 27 partial responses. Three patients had stable disease.
A total of 6 patients had disease downstaging and went on to receive curative therapy. Five patients had R0 resection, and 1 received curative ablation.
The median progression-free survival was 10.38 months, and the median overall survival was not reached.
All patients had treatment-related adverse events (TRAEs), and 74.3% had grade 3 or higher TRAEs. The most common grade 3 or higher TRAEs were decreased lymphocyte counts (37.1%) and neutrophil counts (34.3%).
Thirteen patients had serious adverse events (SAEs), the most common of which was decreased platelet count (14.3%). Immune-related SAEs occurred in 5 patients (14.3%), including immune hepatitis (n=2), immune dermatitis (n=1), reactive cutaneous capillary endothelial proliferation (n=1), and thrombocytopenia (n=1).
“The combination of camrelizumab, apatinib, and HAIC demonstrated encouraging results and manageable safety concerns for HCC at BCLC stage C,” the researchers concluded.
Disclosures: This research was partly supported by Jiangsu Hengrui Pharmaceuticals Co., Ltd. The researchers reported having no disclosures.
Reference
Zhang TQ, Geng ZJ, Zuo MX, et al. Camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and hepatic artery infusion chemotherapy for hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (TRIPLET): A phase II study. Signal Transduct Target Ther. 2023;8(1):413. doi:10.1038/s41392-023-01663-6
This article originally appeared on Cancer Therapy Advisor
