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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting bead transarterial chemoembolization(DEB-TACE) | Active Comparator | 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 | Experimental | PVL and PVE will be performed randomly assigned according to 1:1 according to the random number table. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-TACE | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of tumor resection after treatment | Until one month after the last treatment. | |
| FLR | the ratio of FLR proliferation after treatment | Until one month after the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After operation, up to 3 years |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan-guang Zhang, M.D. | Contact | +8613886195965 | wgzhang@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wan-guang Zhang | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| PVL/PVE+DEB-TACE | Procedure | 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. |
|
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
| 1, 3 year |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |