Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC With Major Portal Vein Tumor Thrombosis

HepatoCellular Carcinoma Clinical Trial

Official title:

Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009461
• Other study ID #: MPVTT
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2017
• Est. completion date: December 28, 2020

Study information

• Verified date: October 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 28, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient must have histologically or clinically confirmed hepatocellular carcinoma.
• HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)
• Child A class
• Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 90g/L
• Total bilirubin =< 2 X institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality
• Creatinine =< 1.5 X institutional upper limit of normal
• Albumin >= 30g/L
• Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

• Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib.
• Patient who is receiving any other investigational agents
• Patient who have a diagnosis of hepatic encephalopathy
• Patients who have a diagnosis of sclerosing cholangitis.
• Patients who have a diagnosis of Gilbert's disease.
• Patients who have clinical ascites
• Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
• No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years
• Patient who is pregnant or lactating
• Patient Allergic to Iodine contrast medium
• Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma
• Portal Vein Thrombosis
• Thrombosis

Intervention

Procedure:
• HAIC
Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.

Drug:
• Sorafenib
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year