On February 25, a pivotal study titled “Transarterial chemoembolization (TACE) combined with camrelizumab and apatinib versus TACE alone in the treatment of unresectable hepatocellular carcinoma eligible for embolization: A multicenter, open-label, randomized, phase 2 study (CAP-ACE) ” was published online in the Journal of Clinical Oncology, the flagship journal of the American Society of Clinical Oncology (ASCO). The study was accomplished under the leadership of Prof. Teng Gaojun, anAcademician of the Chinese Academy of Sciences and Director of the Department of Medicine and Life Sciences at Southeast University, and Director of the Interventional Therapy Center at Zhongda Hospital of Southeast University, in collaboration with 22 centers nationwide. This represents the first multicenter randomized controlled trial independently designed and conducted by Chinese interventional experts using domestically developed original drugs, providing high-level evidence. Both the corresponding and first authors of the paper are from Zhongda Hospital of Southeast University.
Transarterial chemoembolization (TACE) is the primary treatment for intermediate and advanced hepatocellular carcinoma (HCC). In China alone, over 500,000 TACE interventional procedures are performed annually, yet long-term survival outcomes require improvement. Two recently published Phase III clinical trials (EMERALD-1, LEAP-012) have confirmed that TACE combined with targeted therapy and immunotherapy offers superior progression-free survival (PFS) compared to TACE alone, though these trials primarily focused on patients with intermediate-stage HCC.
From December 28, 2020 to October 29, 2023, a total of 200 patients with unresectable HCC were enrolled in this study, with 90% having a tumor burden ≥7.0 cm and 40% classified as advanced stage due to vascular invasion. The study utilized domestically produced camrelizumab and apatinib. Results demonstrated significantly superior median progression-free survival (PFS) in the TACE+targeted therapy/immunotherapy group compared to the TACE alone group, with overall survival follow-up ongoing.
The significance of this study lies in demonstrating that TACE combined with targeted therapy and immunotherapy benefits not only intermediate-stage HCC patients but also those with advanced-stage disease and high tumor burden, providing crucial evidence for the combined treatment strategy. Before this trial, a series of multicenter, large-scale retrospective studies based on the CHANCE cohort (CHANCE001, CHANCE2201, CHANCE2202, CHANCE2211) had already shown that TACE combined with targeted therapy and immunotherapy significantly improves overall survival (OS) in HCC patients. Together with these data and the current study results, a robust body of evidence has been established for the TACE+targeted therapy/immunotherapy regimen in treating intermediate and advanced HCC. This strategy has also been incorporated into the updated Guidelines for the Diagnosis and Treatment of Primary Liver Cancer by China's National Health Commission.
The CHANCE cohort, established under the leadership of Zhongda Hospital Southeast University with participation from over 100 leading hospitals nationwide, focuses on comprehensive treatment data featuring interventional approaches and currently represents the world’s largest liver cancer data cohort for interventional therapy combined with targeted therapy and immunotherapy.
Source: Zhongda Hospital Southeast University
Translated by: Melody Zhang
Proofready by: Gao Min
Edited by: Leah Li
