Ming Zhao, MD

Ming Zhao, MD, professor of oncology in the Department of Minimally Invasive Interventional Radiology at Sun Yat-Sen University Cancer Center, discusses the FOHAIC-1 (NCT03164382) clinical trial examining hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil/leucovorin (FOLFOX; HAIC-FO) versus sorafenib (Nexavar).

The phase 3 study enrolled 262 participants with advanced hepatocellular carcinoma (HCC) who were previously untreated with systemic therapy. Patients were randomized 1:1 to receive either HAIC-FO or sorafenib.

The primary end point was overall survival (OS) with secondary end points consisting of time to progression and time to intrahepatic tumor progression. More often than not, patients had advanced HCC, a performance status of 1 or 2, and a tumor involvement which lodged in 15% of the liver.

The primary objective of this study was OS which compares HAIC-FO and sorafenib. Before we started the study, we assumed the OS in the sorafenib and the HAIC-FO group and we calculated a sample.

 From 2017 to maybe 2 years ago, we finished the study. The best 9 characteristics of these patients are very different from the previous study. These patients have many more advanced HCC and a performance status of 1 or 2. A performance status of 0 is rare. The tumor diameter is very large. The tumor involvement lodges in 15% of the liver and occupied 15.3% of the whole patient.

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Ming Zhao, MD, explains the background of the FOHAIC-1 study.

Discussing the FOHAIC-1 Study for Patients With HCC

Though previous findings have determined that it is common to find advanced hepatocellular carcinoma (HCC) with mega liver masses and macrovascular invasion with the first diagnosis, the best way to treat these patients has not been determined.

Because of this, FOHAIC-1 trial (NCT03164382) was created to look at the hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil/leucovorin (FOLFOX; HAIC-FO) versus sorafenib (Nexavar). The primary endpoint was overall survival with secondary endpoints including time to progression and time to intrahepatic tumor progression.

In an interview with Targeted Oncology™, Ming Zhao, MD, professor of oncology in the Department of Minimally Invasive Interventional Radiology at Sun Yat-Sen University Cancer Center, discusses the results of the FOHAIC-1 clinical trial and how it compares to HAIC-FO for the treatment of HCC.

In this study, the hepatic arterial infusion showed a greater response rate compared with sorafenib. The OS is also much longer in the hepatic arterial infusion group compared to sorafenib. We also conclude the statistical significance in the overall survival and in progression-free survival. In terms of safety, the grade 3/4 AEs were recorded more frequently with sorafenib than with hepatic arterial infusion. Grade 3/4 AEs occurred in only 20.3% of patients in the hepatic arterial infusion arm. The most frequent complication in the hepatic arterial infusion groups is abdominal pain. This occurred in about 14% of patients in our study. This is a main concern. But we used some drugs to alleviate pain.

In an interview with Targeted Oncology™, Ming Zhao, MD, discusses the results of the FOHAIC-1 clinical trial and how it compares to HAIC-FO for the treatment of HCC.

Ming Zhao, MD | Authors

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