Abstract 2395: Camrelizumab combined with apatinib and hepatic artery infusion chemotherapy (HAIC) as conversion therapy for patients with unresectable hepatocellular carcinoma(HCC): A single-arm exploratory clinical study

Abstract Background: There is still no standard treatment recommendation for hepatocellular carcinoma transformation therapy, and researches are still under exploration. Methods: This study was a single-arm phase II trial, eligible patients had histologically or cytologically confirmed unresectable HCC, without extrahepatic metastases and multiple diffuse liver lesions. Patients received camrelizumab and apatinib combined with HAIC for 2-8 cycles followed by surgery after evaluation. Primary endpoints were radiographic assessment of conversion rate and radical (R0) resection rate. Secondary endpoints were pathologic complete response rate (pCR), objective response rate (ORR) by modified RECIST (mRECIST) and RECIST version 1.1(RECIST v1.1) and safety. Results: Between March 17, 2021 and July 28, 2023, 22 patients were enrolled, including 9 (40.9%) patients with BCLC stage A, 2 (9.1%) patient with B, and 11 (50%) patients with C, 9 (40.9%) patients had tumor thrombus. Patients received treatment of a median of 2 cycles (range: 1-6 cycles). All 22 patients were included in thte safety set, before the first scheduled post-baseline tumor assessment, one patient changed treatment plan because of live function damage, three patients were failed to return to hospital for treatment because of civid-19. At the data cut off on 23 November, All other 18 patients conducted at least one efficacy evaluation, 8(44.4%) of 18 patients had an objective response and 16(88.9%) had disease control according to RECISIT v1.1, 3(16.7%) had a complete response, 9(40.9%) had a partial response and 18(88.9%) had disease control according to m RECIST. 15(68.2%) of 22 patients could undergo surgical resection based on imaging evaluation. 7 patients failed to undergo surgery due to CR (3patients), abnormal liver function(1 patient), immune myocarditis(1 patient), patient rejection(1 patient) waiting for surgery(1 patient). Resection was completed in 8 (44.4%) patients, and the R0 resection rate was 100%. The pCR rate in the surgery population was 25%, and the MPR rate is 37.5%. The most common grade 3 adverse events were increased alanine aminotransferase (36.3%) and decreased lymphocyte count (36.3%). A case of grade 4 immune-associated myocarditis occurred. No grade 5 treatment-related toxicity occurred. Conclusion: Camrelizumab combined with apatinib and HAIC showed promising activity and manageable toxicity, and might be a potential conversion treatment option for patients with unresectable HCC. Citation Format: Lei Zhao, Bo Zhang, Xuetao Shi, Kai Cui, Jianxin Zhang, Jingtao Zhong, Zhongchao Li, Pengfei Sun, Chengsheng Zhang, Lei Li. Camrelizumab combined with apatinib and hepatic artery infusion chemotherapy (HAIC) as conversion therapy for patients with unresectable hepatocellular carcinoma(HCC): A single-arm exploratory clinical study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2395.