Back to resultsHAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hepatic arterial infusion chemotherapy
Transarterial chemoembolization
TACE regimen
HAIC Regimen
Oral Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of BCLC C stage 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.
- 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:
- Main portal vein occlusion
- 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.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
Sites / Locations
- Dongguan People's Hospital
- Cancer Center Sun Yat-sen University
- The First Affiliated Hospital, Sun Yat-sen University
- Guangzhou Twelfth People 's Hospital
- Kaiping Central Hospital
- The First Affiliated Hospital of University Of South China
- The First Affiliated Hospital Of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAIC plus sorafenib
TACE plus sorafenib
Arm Description
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
Outcomes
Primary Outcome Measures
Overall survival
Overall survival
Secondary Outcome Measures
Progress free survival
Progress free survival
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856126
Brief Title
HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
Official Title
The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
Detailed Description
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HAIC plus sorafenib
Arm Type
Experimental
Arm Description
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
Arm Title
TACE plus sorafenib
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
Intervention Type
Procedure
Intervention Name(s)
Hepatic arterial infusion chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolization
Intervention Type
Drug
Intervention Name(s)
TACE regimen
Intervention Description
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
Intervention Type
Drug
Intervention Name(s)
HAIC Regimen
Intervention Description
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Intervention Type
Drug
Intervention Name(s)
Oral Sorafenib
Intervention Description
Oral Sorafenib, 400mg, Bid
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progress free survival
Description
Progress free survival
Time Frame
18 months
Title
Adverse Events
Description
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
Time Frame
30 Days
Title
Number of of Patients developed Adverse Events
Description
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Time Frame
30 Days
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 BCLC C stage 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.
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:
Main portal vein occlusion
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.
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Serious non-healing wound, ulcer, or bone fracture
Known central nervous system tumors including metastatic brain disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi, MD
Organizational Affiliation
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangzhou Twelfth People 's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510620
Country
China
Facility Name
Kaiping Central Hospital
City
Kaiping
State/Province
Guangdong
ZIP/Postal Code
529300
Country
China
Facility Name
The First Affiliated Hospital of University Of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
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