320
Participants
Start Date
April 1, 2025
Primary Completion Date
March 31, 2029
Study Completion Date
March 31, 2030
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."
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."
RECRUITING
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou
Affiliated Hospital of Guangdong Medical University
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Huizhou Municipal Central Hospital
OTHER
Jieyang People's Hospital
OTHER
Guangzhou Development District Hospital
UNKNOWN
First People's Hospital of Foshan
OTHER
Anqing Municipal Hospital
OTHER
Jinan University Affiliated Shunde Hospital
UNKNOWN
Second Affiliated Hospital of Guangzhou Medical University
OTHER