NCT05788835

DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial

Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Xuhua Duan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC

Detailed description

Primary liver cancer is one of the most common malignant tumors in the world. According to the survey results of the BRIDGE study, about 64% of Chinese patients with liver cancer had BCLC stage B and stage C at the first diagnosis, and the vast majority of patients in the middle and advanced stages were no longer suitable for the first choice of surgical resection and should receive comprehensive treatment mainly consisting of local treatment and systemic treatment. TACE is one of the most used treatments for liver cancer. At present, cTACE and DEB-TACE are mainly used. Drug-eluting beads, as new drug-carrying embolisms, have the advantages of loading chemotherapeutic drugs depending on charge and releasing drugs slowly within a certain time to improve local drug concentration. Based on the application of clinical practice, its efficacy has been well confirmed. DEB-TACE results in better tumor response and a similar safety profile than cTACE. However, for HCC at stage C of BCLC, due to the large tumor load and common portal invasion, it is difficult for a single TACE to achieve complete or partial remission, and a complete embolization is likely to increase the risk of serious complications. Hepatic Arterial Infusion Chemotherapy is used to treat hepatic arterial infusion chemotherapy (HCC). HAIC requires chemotherapy drugs to be injected directly into the liver tumor via a percutaneous arterial cannula. HAIC drugs alone stay in the tumor for a short time, will be washed out quickly, and cannot be completely covered for tumors with external hepatic collateral circulation. However, unlike HAIC, DEB-TACE can embolize tumors to nourish arteries, rapidly lead to massive ischemic necrosis of tumors, and significantly prolong the contact time between cancer cells and chemotherapy drugs. In conclusion, the combination of DEB-TACE and HAIC can make up for the respective deficiencies of DEB-TACE and HAIC. And produce enhanced local anti-tumor effect and less AEs, especially in HCC with high tumor load. The combination of DEB-TACE and HAIC has been well tolerated in the treatment of large liver cancer. However, most patients with BCLC stage C HCC have vascular invasion or extrahepatic metastasis, which cannot be treated surgically. Moreover, the progressive involvement of vascular invasion will eventually reduce blood flow and further deteriorate liver function, resulting in impaired liver function and poor prognosis. Therefore, we predict that the DEB-TACE sequential HAIC approach will reduce AEs while achieving good efficacy. Therefore, based on previous studies, this study intended to select patients with unresectable primary liver cancer at stage C of BCLC in a multi-center setting, and prospectively observe the efficacy of DEB-TACE followed by FOLFOX-based HAIC in the treatment of unresectable BCLC stage C patients.

Conditions

• HCC

Interventions

Type	Name	Description
PROCEDURE	DEB-TACE and HAIC	Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion
PROCEDURE	DEB-TACE	Drug-eluting bead transarterial chemoembolization

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-06-07
• Completion: 2026-06-30
• First posted: 2023-03-29
• Last updated: 2023-03-29

Locations

16 sites across 1 country: China