Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

PHASE2RecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2030

Conditions
Hepatocellular Carcinoma Non-resectable
Interventions
COMBINATION_PRODUCT

LEN+SIN+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 and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC."

COMBINATION_PRODUCT

LEN+SIN+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 and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE."

Trial Locations (1)

510260

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Huizhou Municipal Central Hospital

OTHER

collaborator

Jieyang People's Hospital

OTHER

collaborator

Guangzhou Development District Hospital

UNKNOWN

collaborator

First People's Hospital of Foshan

OTHER

collaborator

Anqing Municipal Hospital

OTHER

collaborator

Jinan University Affiliated Shunde Hospital

UNKNOWN

lead

Second Affiliated Hospital of Guangzhou Medical University

OTHER