Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

PHASE3RecruitingINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Hepatocellular Carcinoma Non-resectable
Interventions
COMBINATION_PRODUCT

Len+DEB-TACE+HAIC

"For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. 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 main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.~During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.~Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC."

COMBINATION_PRODUCT

Len+DEB-TACE

"For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. 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. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.~Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC."

Trial Locations (1)

510260

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
lead

Second Affiliated Hospital of Guangzhou Medical University

OTHER