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
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
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
NCT ID
NCT03775395
First Posted
December 12, 2018
Last Updated
January 1, 2019
Sponsor
Sun Yat-sen University
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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