This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
For Unresectable Hepatocellular Carcinoma (uHCC) patients, Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with PD-1 inhibitors treatment is an important choice, which can achieve deeper tumor remission. However, there are still some patients whose lesions have not reached complete response after treatment. According to research, patients with complete response of lesions after conversion therapy have a more ideal long-term survival rate. For populations that have not yet achieved complete response, sequential radiotherapy will achieve deeper tumor remission, delay recurrence, and achieve better oncological outcomes. This study is a single arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of TACE, Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in the treatment of uHCC patients.
Study Type
OBSERVATIONAL
Enrollment
28
TACE, Lenvatinib \[8mg(\<60kg)/12mg(\>60kg) orally daily\] combination with Sintilimab (200mg administered intravenous injection on Day 1 of each 21-day cycle) for 2 months. Sequential radiotherapy method and dosage are comprehensively evaluated by radiologists, hepatobiliary surgeons, and oncologists, and discussed by a multidisciplinary team
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGFujian provincial hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGObjective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to RECIST 1.1.
Time frame: 4 weeks after the initiation of medication until the day before surgery
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 randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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 randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to mRECIST.
Time frame: 4 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: 3 months
Major pathological response rate, MPR rate
The major pathological response (MPR) rate was defined as less than 10% active tumor cells in the excised tissue sample in patients accept operation.
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Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGTime frame: Immediately after surgery
Toxicity Adverse events
Grade 1-5 AEs according to NCI-CTCAE V5.0.
Time frame: through study completion, assessed up to 60 months