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

Primary Purpose

HepatoCellular Carcinoma, Portal Vein Thrombosis

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HAIC

Sorafenib

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma focused on measuring Hepatocellular carcinoma, Portal vein tumor thrombosis, Hepatic arterial infusion chemotherapy, Sorafenib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sor-HAIC group

Sor group

Arm Description

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic 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.

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03009461

First Posted

January 2, 2017

Last Updated

October 8, 2021

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03009461

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

June 15, 2020 (Actual)

Study Completion Date

December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HepatoCellular Carcinoma, Portal Vein Thrombosis

Keywords

Hepatocellular carcinoma, Portal vein tumor thrombosis, Hepatic arterial infusion chemotherapy, Sorafenib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sor-HAIC group

Arm Type

Experimental

Arm Description

Arm Title

Sor group

Arm Type

Active Comparator

Arm Description

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Intervention Type

Procedure

Intervention Name(s)

HAIC

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35103539

Citation

Zheng K, Zhu X, Fu S, Cao G, Li WQ, Xu L, Chen H, Wu D, Yang R, Wang K, Liu W, Wang H, Bao Q, Liu M, Hao C, Shen L, Xing B, Wang X. Sorafenib Plus Hepatic Arterial Infusion Chemotherapy versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis: A Randomized Trial. Radiology. 2022 May;303(2):455-464. doi: 10.1148/radiol.211545. Epub 2022 Feb 1.

Results Reference

derived

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

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