PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: DEB-TACEProcedure: PVL/PVE+DEB-TACE
- Registration Number
- NCT05103007
- Lead Sponsor
- Tongji Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
- Child-Pugh liver function grade A,
- ECOG PS 0-1
- If the tumor is resected with R0, the remaining liver volume is insufficient
- ICG-15R < 30%
- No serious organic diseases of heart, lung, brain and other organs;
- No history of other malignant tumors;
- The patient's survival time is expected to be more than 3 months.
- Pregnant and lactating women
- History of organ transplant
- Tumor thrombus with portal vein trunk or left branch involved;
- distant metastasis;
- Patients with obvious liver cirrhosis (Plt < 100 × 10 ^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
- Active bleeding caused by various causes;
- Suffering from severe acute or chronic diseases or infectious diseases;
- History of hepatectomy or TACE treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug-eluting bead transarterial chemoembolization（DEB-TACE) DEB-TACE Percutaneous drug-eluting bead transarterial chemoembolization, followed by conventional transarterial chemoembolization（cTACE) every 2 months. A total of 3 times of chemoembolization will be performed. PVL/PVE+DEB-TACE PVL/PVE+DEB-TACE PVL and PVE will be performed randomly assigned according to 1:1 according to the random number table.
- Primary Outcome Measures
Name Time Method FLR Until one month after the last treatment. the ratio of FLR proliferation after treatment
the rate of tumor resection after treatment Until one month after the last treatment.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) After operation, up to 3 years 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.
Progression-free survival (PFS) 1, 3 year 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
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China