- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605734
TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
May 21, 2012 updated by: Jinlong Song, Shandong Cancer Hospital and Institute
Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
TACE is widely used in patients with unresectable HCC.
However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed.
Sorafenib is regarded as standard treatment for advanced HCC.
It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinlong Song, MD
- Phone Number: +8653167626411
- Email: songjlmd@gmail.com
Study Contact Backup
- Name: Wenbo Shao, MD,Ph D
- Phone Number: +8653167626412
- Email: shaowenbomd@gmai.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Shandong Cancer Hospital and Institute
-
Jinan, Shandong, China, 250021
- Shandong Medical Imaging Research Institute
-
Contact:
- Jun Tang, MD
- Phone Number: +8613964031909
- Email: tangjun7925032@163.com
-
Principal Investigator:
- Jun Tang, MD
-
Jinan, Shandong, China, 250114
- Qilu Hospital of Shandong University
-
Contact:
- Caixia Li, MD
- Phone Number: +8613505312972
- Email: Lilyshanda88@hotmail.com
-
Principal Investigator:
- Caixia Li, MD
-
Qingdao, Shandong, China, 266003
- The Affiliated Hospital of Medical College Qingdao University
-
Contact:
- Zixiang Li, MD
- Phone Number: +8618669739263
- Email: zixiangli@yahoo.com.cn
-
Principal Investigator:
- Zixiang Li, MD
-
Yantai, Shandong, China, 264000
- Yantai Yuhuangding Hospital
-
Contact:
- Yanbo Zheng, MD
- Phone Number: +8613805356068
- Email: 13805356068@163.com
-
Principal Investigator:
- Yanbo Zheng
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- BCLC stage B or C
- Child-Pugh class score≤8
- ECOG performance status ≤2
- Etiology: Hepatitis B virus(HBV) infection
- Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
- Patient must be able to comply with the protocol
- Age 18-75 years
- Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal,Prealbumin>0.5x the lower limit of normal.
- Life expectancy of > 3 months
Exclusion Criteria:
- BCLC stage D
- Child-Pugh Score≥9
- Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
- Preexisting or history of hepatic encephalopathy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
- Serious, non-healing wound, ulcer, or bone fracture
- Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
- Other severe concomitant disease that may reduce life expectancy
- Risk of allergic reactions to the study drugs
- Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group TACE
TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles.
TACE will be repeated if clinically indicated
|
After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
|
Experimental: Group Combination
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
|
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: 1 year
|
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FACT-Hep
Time Frame: six months
|
FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks
|
six months
|
Disease control rate
Time Frame: six months after TACE
|
CR+PR+SD
|
six months after TACE
|
Safety
Time Frame: six months
|
Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
|
six months
|
PFS and OS
Time Frame: two years
|
The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively
|
two years
|
Number of TACE sessions and the interval time between two TACE sessions
Time Frame: 2 years
|
2 years
|
|
AFP
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jinlong Song, MD, Shandong Cancer Hospital and Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 11, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (Estimate)
May 25, 2012
Study Record Updates
Last Update Posted (Estimate)
May 25, 2012
Last Update Submitted That Met QC Criteria
May 21, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Chlorotrianisene
- Sorafenib
Other Study ID Numbers
- ShandongCHI-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Hepatocellular
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditionsUnited States
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCActive, not recruitingAdvanced Adult Hepatocellular Carcinoma | Child-Pugh Class A | Stage III Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI); Genentech, Inc.RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditionsUnited States, Canada, Puerto Rico
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingAdvanced Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma | BCLC Stage A Hepatocellular CarcinomaUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)CompletedStage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular CarcinomaUnited States
-
Edward KimBristol-Myers Squibb; National Cancer Institute (NCI)TerminatedUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
Clinical Trials on TACE
-
Beijing Tsinghua Chang Gung HospitalUnknownHepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)China
-
Beijing Tsinghua Chang Gung HospitalUnknownHuge Hepatocellular Carcinoma (HCC) (≥10cm)China
-
Shanghai Zhongshan HospitalRecruitingA Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCCHepatocellular Carcinoma | DonafenibChina
-
Eastern Hepatobiliary Surgery HospitalCompletedHepatocellular CarcinomaChina
-
Sun Yat-sen UniversityUnknownHepatocellular Carcinoma | Liver CancerChina
-
Sun Yat-sen UniversityUnknownHepatocellular Carcinoma | Liver CancerChina
-
Fudan UniversityUnknownHepatocellular CarcinomaChina
-
Kindai UniversityUnknownCarcinoma, Hepatocellular | Hepatocellular Carcinoma | Liver Neoplasm | Unresectable Hepatocellular CarcinomaJapan
-
Ivy Life Sciences, Co., LtdTri-Service General HospitalUnknownLiver Cancer | HepatoCellular CarcinomaTaiwan
-
Assiut UniversityUnknown