Clinical trial NCT05103007: PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer
Official title: A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Drug-eluting bead transarterial chemoembolization(DEB-TACE)
portal vein embolization(PVE)
portal vein ligation(PVL)
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the rate of tumor resection after treatment
timeFrame: Until one month after the last treatment.
measure: FLR
timeFrame: Until one month after the last treatment.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: After operation, up to 3 years
measure: Progression-free survival (PFS)
timeFrame: 1, 3 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wan-guang Zhang
role: PRINCIPAL_INVESTIGATOR
References: