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HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lenvatinib
Sorafenib
Hepatic arterial infusion chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Hepatic artery infusion chemotherapy, Sorafenib, Lenvatinib

Eligibility Criteria

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

Inclusion Criteria:

  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
  • Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
  • Barcelona clinic liver cancer-stage C
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • with no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
  • The following laboratory parameters:
  • Platelet count ≥ 75,000/μL
  • Hemoglobin ≥ 8.5 g/dL
  • Total bilirubin ≤ 30mmol/L
  • Serum albumin ≥ 30 g/L
  • ASL and AST ≤ 5 x upper limit of normal
  • Serum creatinine ≤ 1.5 x upper limit of normal
  • INR ≤ 1.5 or PT/APTT within normal limits
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known central nervous system tumors including metastatic brain disease

Sites / Locations

  • Cancer Center Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAIC plus Lenvatinib

HAIC plus Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall survival
Overall survival

Secondary Outcome Measures

Time to progression
Time to progression
Adverse Events
Progression Free Survival (PFS)

Full Information

First Posted
December 12, 2018
Last Updated
January 1, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03775395
Brief Title
HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC
Official Title
Hepatic Artery Infusion Chemotherapy Plus Lenvatinib vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Hepatic artery infusion chemotherapy, Sorafenib, Lenvatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAIC plus Lenvatinib
Arm Type
Experimental
Arm Title
HAIC plus Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
12 mg (or 8 mg) once daily (QD) oral dosing.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
400mg BID daily oral dosing
Intervention Type
Procedure
Intervention Name(s)
Hepatic arterial infusion chemotherapy
Intervention Description
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
Time Frame: 12 months
Secondary Outcome Measure Information:
Title
Time to progression
Description
Time to progression
Time Frame
Time Frame: 12 months
Title
Adverse Events
Time Frame
[Time Frame: 30 days]
Title
Progression Free Survival (PFS)
Time Frame
Time Frame: 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. Barcelona clinic liver cancer-stage C Eastern Cooperative Oncology Group performance status of 0 to 2 with no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment. The following laboratory parameters: Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. Known central nervous system tumors including metastatic brain disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shi, MD
Phone
+862087343938
Email
shiming@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Phone
8620-87343115
Email
shiming@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

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