Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: PVIC, TACE

• Registration Number: NCT01033578
• Lead Sponsor: Fudan University

Brief Summary

The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).

Detailed Description

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major cause of cancer-related death. HCC is characterized by its propensity for portal vein invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is dismal. The median survival of such patients was reported to be 2.7 mouths.

Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has been reported to achieve promising results. However, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for HCC with PVTT.

There is rare report about prevention and treatment of postoperative recurrence and metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required further prospective randomized controlled studies with large case number to support our findings. The randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and PVTT.

Study Timeline

• Study Start: 1999-10
• Status Verified: 2009-10
• Primary Completion: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Last Update Submitted: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Posted: 2009-12-16
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Age 18 to 75 years
2. Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology.
3. No extrahepatic metastasis
4. No previous management
5. The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
6. Good or moderate hepatic function (Child-Pugh Class A or B)
7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria

1. Refuse to participate
2. Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 * 109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of normal, which could not recover after treatment
3. Ascites refractory to diuretics
4. Variceal bleeding
5. Severe diseases of the heart or Lung

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	PVIC, TACE	Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
PVIC Group	PVIC, TACE	Portal Vein Infusion Chemotherapy (PVIC): 5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) was continuously infused into portal vein through tube by a infusion pump implanted in operation. Treatment started 2 weeks after the operation and was repeated every 4 weeks for six cycles.
TACE Group	PVIC, TACE	Transcatheter Arterial Chemoembolization (TACE): 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles.
PVIC+TACE Group	PVIC, TACE	Combination of PVIC and TACE. PVIC started 2 weeks after operation and TACE started 6 weeks after operation. Both PVIC and TACE were repeated at 8 weeks intervals for 3 cycles.

Primary Outcome Measures

Name	Time	Method
Overall Survival	1-year, 3-year, 5-year

Secondary Outcome Measures

Name	Time	Method
Time to Recurrence	1-year, 3-year, 5-year

Trial Locations

Locations (1)

Liver Cancer Insitute, Zhongshan Hospital; 🇨🇳 Shanghai, China