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

Sun Yat-sen University

Status and phase: Terminated; Phase 4

Conditions: Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Treatments: Procedure: Liver resection plus Thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01600196

HCC2005009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups

Resection arm

Experimental group

Description:

Liver resection Plus Thrombectomy

Treatment:

Procedure: Liver resection plus Thrombectomy

Best support care arm

No Intervention group

Description:

Best supportive care