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

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Fudan University

Status

Unknown

Conditions

Hepatocellular Carcinoma

Treatments

Other: PVIC, TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT01033578
Fudan-LCI-PVTT-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

260 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 to 75 years 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. No extrahepatic metastasis No previous management The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography Good or moderate hepatic function (Child-Pugh Class A or B) Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion criteria

Refuse to participate 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 Ascites refractory to diuretics Variceal bleeding Severe diseases of the heart or Lung

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

260 participants in 4 patient groups

Control
No Intervention group
Description:
Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
Treatment:
Other: PVIC, TACE
PVIC Group
Experimental group
Description:
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.
Treatment:
Other: PVIC, TACE
TACE Group
Experimental group
Description:
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.
Treatment:
Other: PVIC, TACE
PVIC+TACE Group
Experimental group
Description:
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.
Treatment:
Other: PVIC, TACE

Trial contacts and locations

1

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Central trial contact

Xiaoying Wang, Doctor; Jia Fan, Doctor

Data sourced from clinicaltrials.gov

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