NCT05171166

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.

Detailed description

Trans-arterial chemoembolization (TACE) is the most widely used palliative treatment for BCLC B stage hepatocellular carcinoma (HCC) patients. While a number of studies demonstrated poor effect of TACE for patients with large hepatocellular carcinoma especially for those with tumor that out of up-to-7 criteria. Some recent studies suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large tumor. Thus, the investigators carried out this prospective randomized controlled trial to demonstrate the superiority of neoadjuvant HAIC of TACE. Total 156 subjects will be recruited in this study, each group of 78 subjects in treatment group (HAIC-TACE-Dona group) and control group (TACE-Dona group). Primary efficacy analysis will be done in the full analysis set. PFS will be used as primary outcome measures. OS, TTP, ORR, DCR and safety will be the secondary endpoints. In addition, the safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	HAIC	Hepatic arterial infusion chemotherapy is consist of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 would be intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.
PROCEDURE	TACE	A standard hepatic artery catheter would be introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery would be performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply, the proportion of the liver supplied by each artery would be estimated by the arteriography. After optimal positioning of the catheter, cTACE or DEB-TACE protocol would be performed to embolize the tumor supplying artery blood flow until the stasis of the supplying artery.
DRUG	FOLFOX	oxaliplatin,leucovorin, and 5-FU
DRUG	cTACE or DEB-TACE	lipiodol or microspheres that mixed with EPI
DRUG	Donafenib	200 mg of donafenib (consisting of two 100-mg tablets) twice daily.

Timeline

• Start date: 2021-12-24
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2021-12-28
• Last updated: 2025-12-18

Locations

1 site across 1 country: China