TACE With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma
Information source: Fourth Military Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: Sorafenib (Drug); TACE (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Fourth Military Medical University Official(s) and/or principal investigator(s): Guohong Han, MD, Principal Investigator, Affiliation: Xijing Hospital of Digestive Disease, Fourth Military Medical University
Overall contact: Guohong Han, MD, Phone: +862984771528, Email: guohhan@126.com
Summary
This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE
combined with sorafenib compared with TACE monotherapy in term of overall survival in
intermediate-stage HCC.
Clinical Details
Official title: Transarterial Chemoembolization (TACE) With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma: a Multicenter Prospective Nonrandomized Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Overall survival
Secondary outcome: Time to progressionTumor response Adverse events
Detailed description:
Sorafenib, a multikinase inhibitor, has been successfully applied for solid tumors such as
renal cancer and HCC.
According to the Barcelona Clinic Liver Cancer (BCLC) staging classification, transarterial
chemoembolization (TACE) has been recommended as a first line-therapy for patients at
intermediate stage - BCLC B class (multinodular asymptomatic tumors without an invasive
pattern).
Because sorafenib may improve the efficacy of locoregional therapy by decreasing post-TACE
angiogenesis, sorafenib in combination with TACE has attracted considerable attention as a
promising therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Prior informed consent
2. Intermediate stage HCC/ BCLC B stage
3. Confirmed Diagnosis of HCC:
1. Cirrhotic subjects: Clinical diagnosis by AASLD criteria. HCC can be defined in
cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation
contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in
the arterial phase and washout in venous or late phases or two imaging
techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
Cytohistological confirmation is required for subjects who do not fulfill these
eligibility criteria.
2. Non-cirrhotic subjects: For subjects without cirrhosis, histological or
cytological confirmation is mandatory. Documentation of original biopsy for
diagnosis is acceptable
4. Child Pugh class A/B(7) class without ascites or hepatic encephalopathy
5. ECOG Performance Status of 0-1
6. At least one uni-dimensional lesion measurable by CT-scan or MRI according to the
RECIST 1. 1, mRECIST and EASL criteria, respectively.
1. Single lesion>5cm
2. 2-3 lesions, at least one lesion>3cm; if more than 4 lesions, no limitation of
the tumor size, but the sum of size of all tumor lesions should be less than 50%
of liver parenchyma.
7. Male or female subject ≥ 18 years of age
8. Ability to swallow oral medications
9. Life expectancy of at least 12 weeks
10. Pregnancy test negative within 14 days before treatment. Both men and women enrolled
in this trial must use adequate barrier birth control measures during the course of
the trial and 4 weeks after the completion of trial
11. Adequate bone marrow, liver and renal functions as assessed by central lab by means
of the following laboratory requirements from samples within 7 days prior to
randomization:
1. Hemoglobin > 9. 0 g/dl
2. Absolute neutrophil count (ANC) >1,500/mm3
3. Platelet count ≥50x109/L
4. ALB ≥28g/L
5. Total bilirubin < 2 mg/dL
6. ALT and AST < 5 x upper limit of normal
7. BUN and creatinine < 1. 5 x upper limit of normal
8. INR < 1. 7, or PT < 4 seconds above control
Exclusion Criteria:
1. Diffuse HCC or tumor size ≥50% of liver parenchyma
2. Vascular invasion
3. Presence of extrahepatic metastasis
4. Poor blood supply for the liver tumor lesions; poor blood supply refers that the
tumor lesions fail to show obvious contrast uptake in the arterial phase and washout
in venous or late phases by CT scan or MRI
5. Any contraindications for hepatic embolization procedures:
1. Known hepatofugal blood flow
2. Known porto-systemic shunt
3. Renal failure / insufficiency requiring hemo-or peritoneal dialysis
6. Target lesions having previously been treated with local therapy such as resection of
HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI)
7. Investigational drugs or other molecular target drugs ongoing or completed < 4 weeks
prior to the baseline scan
8. Prior transarterial embolization or anti-tumor systemic chemotherapy
9. Any ≥ CTC AE grade 2 acute toxic effects of any prior local treatment
10. Patients with untreated varices or active bleeding
11. History of cardiac disease:
1. Congestive heart failure >New York Heart Association (NYHA) class 2
2. Uncontrolled hypertension
12. Known history of HIV infection
13. Active clinically serious infections (> grade 2 NCI-CTCAE Version 4. 0), except for
HBV and HCV infection
14. Clinically significant gastrointestinal bleeding within 4 weeks prior to start of
study drug
15. Thrombotic or embolic events such as cerebrovascular accident (including transient
ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months
prior to the first dose of study drug
16. Previous or concurrent cancer that is distinct in primary site or histology from HCC.
Any cancer curatively treated >3 years prior to entry is permitted
17. Any contraindication for sorafenib or doxorubicin administration
18. Pregnant or breast-feeding subjects
19. Any disease which could affect the evaluation of the study drug: unstable angina,
active CAD, uncontrolled arrhythmias, and myocardial infarction
20. Any condition that is unstable or could jeopardize the safety of the subject and
their compliance in the study
21. Major surgery within 4 weeks prior to start of study drug (e. g. thoracolaparotomy is
not allowed, but noninvasive surgery, e. g. biopsy, is allowed)
22. Autologous bone marrow transplant or stem cell rescue within 1 year prior to start of
study drug
23. History of organ allograft
Locations and Contacts
Guohong Han, MD, Phone: +862984771528, Email: guohhan@126.com
Xijing Hospital of digestive disease, Fourth Military Medical University, Xi'an, Shaanxi 710032, China
Additional Information
Starting date: August 2015
Last updated: August 19, 2015
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