This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.
Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma(HCC)which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
It is suggested that the tumor feeding artery should be selected for the microcatheter. The mixed volume of pirarubicin 80mg + microsphere 2g is about 2ml, and the mixture of at least 10ml and contrast medium is slowly injected with 5-10min.
DEB-TACE will be performed after the liver function recovered within 7-10 days. After that, conventional transarterial chemoembolization(cTACE) was performed every 2 months, a total of 2-3 times of chemoembolization.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGthe rate of tumor resection after treatment
Time frame: Until one month after the last treatment.
FLR
the ratio of FLR proliferation after treatment
Time frame: Until one month after the last treatment.
Overall survival (OS)
The overall survival time refers to the time from the first interventional therapy to the patient's death or the last follow-up, whichever appears early.
Time frame: After operation, up to 3 years
Progression-free survival (PFS)
Disease progression-free survival time refers to the imaging evaluation of the patient after the first interventional therapy, the tumor does not continue to grow, new, distant metastasis; there is no increase in alpha-fetoprotein
Time frame: 1, 3 year
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