This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).
Surgical resection is considered to be the treatment of choice for Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT), but a significant proportion of patients with HCC combined with BDTT are unable to undergo surgical treatment at the time of initial diagnosis. For patients with unresectable advanced HCC combined with BDTT, conversion therapy is particularly important. Currently, there is relatively little literature related to the conversion treatment of HCC with BDTT. Several studies have confirmed that the transcatheter arterial chemoembolization (TACE), lenvatinib, combined with Tislelizumab (Triple Therapy) for the treatment of intermediate-advanced HCC can achieve better efficacy with an acceptable safety. However, there are no clinical studies or relevant literature reports on Triple Therapy for the treatment of HCC with BDTT. The present study is a multicenter, Single-arm, Real-world Study designed to evaluate the efficacy and safety of a triple therapy for the treatment of patients with HCC with BDTT.
Study Type
OBSERVATIONAL
Enrollment
20
TACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Tislelizumab (200mg administered intravenous injection on Day 1 of each 21-day cycle). After the triple therapy, surgical resection is an option if assessed by the investigator to be feasible, or continued until disease progression or intolerable if not.
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
Objective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.
Time frame: Four weeks after the initiation of medication until the day before surgery
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
The Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to mRECIST.
Time frame: Four weeks after the initiation of medication until the day before surgery
Conversion resection rate, CRR
The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Time frame: Four weeks after the initiation of medication until the day before surgery
Toxicity Adverse events
Grade 1-5 AEs according to NCI-CTCAE V5.0.
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Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGFirst Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGZhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
NOT_YET_RECRUITINGTime frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months