Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients

Naval Military Medical University (Second Military Medical University)

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombus

Treatments: Drug: treatment with endostar, CBP and 5-FU; Drug: treatment with CBP and 5-FU; Drug: chemotherapy with endostar

Study type: Interventional

Funder types: Other

Identifiers

NCT00849264

EHBH-RCT-2008-004

Details and patient eligibility

About

This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Full description

Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC.

In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT.

The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Enrollment: 120 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients > 30 years and <=60 years of age.
• with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy.
• resectable tumors in the liver.
• PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination.
• liver function grade A or B of the Child-Pugh classification.
• No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥95g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³.
• Patients who can understand this trial and have signed information consent.

Exclusion criteria

• have had an allergic reaction following iodine or chemotherapeutic drugs.
• with extrahepatic metastasis.
• Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
• liver function:Child C.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

A

Experimental group

Description:

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar

Treatment:

Drug: chemotherapy with endostar

B

Active Comparator group

Description:

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with CBP and 5-FU

Treatment:

Drug: treatment with CBP and 5-FU

C

Experimental group

Description:

PLC patients with PVTT underwent hepatectomy and portal thrombectomy followed by portal vein chemotherapy with endostar, CBP and 5-FU

Treatment:

Drug: treatment with endostar, CBP and 5-FU