Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.

Detailed Description
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Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.

Official Title
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Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

Conditions
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Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Intervention / Treatment
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* Procedure: Liver resection plus Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of HCC was made according to AASLD guidelines Main tumor ≥ 7 cm Imaging confirmed the presence of PVTT in the first branches but not Extend into the main trunk of portal vein Eastern Co-operative Group performance Resectable disease Exclusion Criteria: Child-Pugh class B or C liver cirrhosis An American Society of Anesthesiologists (ASA) score ≥ 3 Extrahepatic metastasis Patients had access to sorafenib.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resection arm<br>Liver resection Plus Thrombectomy | Procedure: Liver resection plus Thrombectomy<br>* Liver resection plus Thrombectomy<br>* Other names: Removal of all tumor tissue by surgery;|
| No Intervention: Best support care arm<br>Best supportive care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus