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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

December 24, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Hepatocellular Carcinoma
Interventions
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.

Trial Locations (1)

100142

RECRUITING

Peking University Cancer Hospital, Beijing

All Listed Sponsors
lead

Peking University

OTHER