DEB-TACE+HAIC vs. HAIC for Large HCC

PHASE3RecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

February 10, 2022

Primary Completion Date

February 9, 2026

Study Completion Date

February 9, 2026

Conditions
Unresectable Hepatocellular Carcinoma
Interventions
PROCEDURE

dTACE-HAIC

"For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.~After each chemoembolization, the microcatheter is reserved at the proper/left/right hepatic artery. The FOLFOX-based regimen is intra-arterially administered.~During follow-up, the treatment will be repeated on demand (at a 4-6-week interval usually) based on the evaluation of the follow-up laboratory and imaging examination."

PROCEDURE

HAIC

"HAIC treatment is divided into 3-week cycles. The microcatheter is advanced into the proper/left/right hepatic artery on day 1 in every cycle of treatment. After the patient returned to the ward, the FOLFOX-based regimen is intra-arterially administered though the microcatheter.~The treatment is repeated once every 3 weeks for up to six cycles."

DRUG

dTACE-HAIC protocol

"CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.~FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h."

DRUG

HAIC protocol

FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.

Trial Locations (1)

510260

RECRUITING

the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
collaborator

Hainan General Hospital

OTHER

collaborator

Maoming People's Hospital

OTHER

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

First People's Hospital of Foshan

OTHER

collaborator

Jiangmen Central Hospital

OTHER

collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

lead

Second Affiliated Hospital of Guangzhou Medical University

OTHER