Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
Conditions
Advanced Hepatocellular Carcinoma - Carcinoma - Carcinoma, Hepatocellular - Liver Neoplasms - Neoplasms
Conditions: official terms
Carcinoma - Carcinoma, Hepatocellular - Liver Neoplasms - Neoplasms
Conditions: Keywords
sorafenib, Hepatic intraarterial infusion chemotherapy, HAIC, Low dose FP, cisplatin, fluorouracil
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Sorafenib with Low-dose FP Type: Drug
Name: Sorafenib Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.
Detailed Description
Sorafenib with Low-dose FP Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system.

Sorafenib Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days.

The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. 20 Years and older.

2. Life expectancy of at least 12 weeks at the pre-treatment evaluation.

3. Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.

4. Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.

5. ECOG Performance status of 0 or 1.

6. Cirrhotic status of Child-Pugh score ≤ 7.

7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:

- Hemoglobin ≥8.5 g/dl

- Granulocytes≥1500/μL

- Platelet count ≥50,000 /μL

- PT-INR ≤ 2.3

- Total serum bilirubin ≤ 2 mg/dl

- AST(SGOT) and ALT(SGPT) ≤ 6 × upper limit of normal

- Serum creatinine ≤ 1.5 × upper limit of normal

- Amylase ≤ 2 × upper limit of normal

8. Written Informed Consent must be obtained.

Exclusion Criteria:

1. Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry

2. Renal failure

3. Any heart disease as follows

- Congestive heart failure defined as NYHA class III or IV

- Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening

- Serious cardiac arrhythmia

- Serious hypertension

4. Active clinically serious infections except for HBV and HCV

5. Active chicken pox.

6. Auditory disorder.

7. Known history of HIV infection.

8. Known metastatic or meningeal tumors.

9. Extrahepatic tumor spread which affects patient's prognosis

10. History of seizure disorder.

11. Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.

12. Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization.

13. Any history of treatment as follows:

- Treatment with the agent which induces CYP3A4

- Surgical procedure within 4 weeks prior to start of study drug

- History of organ allograft

14. Patients unable to swallow oral medications.

15. Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.

16. Medication that may affect to the absorption of drug or pharmacokinetics.

17. Any disease or disorder that may affect the evaluation of study drug.

18. Entry to the other clinical trial within 4 weeks prior to entry to this study.

19. Pregnant or breast-feeding patients.

20. Known allergy to the investigational agent or any agent given in association with this trial.

21. Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.

22. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Locations
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Status: Recruiting
Contact: Masafumi Ikeda, Dr.
Kurume University Medical Center
Kurume, Fukuoka, Japan
Status: Recruiting
Contact: Masatoshi Tanaka, Professor
Ogaki Municipal Hospital
Ogaki, Gifu, Japan
Status: Recruiting
Contact: Takashi Kumada, Dr
Sapporo Medical University
Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Junji Kato, Dr.
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Takumi Ohmura, Dr.
Japanese Red Cross Takamatsu Hospital
Takamatsu, Kagawa, Japan
Status: Recruiting
Contact: Chikara Ogawa, Dr.
Mie University Hospital
Tsu, Mie, Japan
Status: Recruiting
Contact: Katsuya Shiraki, Dr.
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan
Status: Recruiting
Contact: Hiromi Ishibashi, Dr.
Kawasaki Medical School Hospital
Kurashiki, Okayama, Japan
Status: Recruiting
Contact: Keisuke Hino, Dr.
Ikeda Municipal Hospital
Ikeda, Osaka, Japan
Status: Recruiting
Contact: Yasuharu Imai, Dr.
Kinki University Hospital
Osaka-Sayama, Osaka, Japan
Status: Recruiting
Contact: Masatoshi Kudo, Professor - +81-72-366-0221 - m-kudo@med.kindai.ac.jp
Osaka University Hospital
Suita, Osaka, Japan
Status: Recruiting
Contact: Hiroaki Nagano, Professor
Kyorin University Hospital
Mitaka, Tokyo, Japan
Status: Recruiting
Contact: Junji Furuse, Professor
Musashino Red Cross Hospital
Musashino, Tokyo, Japan
Status: Recruiting
Contact: Namiki Izumi, Dr.
Juntendo University Nerima Hospital
Nerima, Tokyo, Japan
Status: Recruiting
Contact: Shigehiro Kokubu, Dr.
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Status: Recruiting
Contact: Isao Sakaida, Prof
Chiba University Hospital
Chiba, Japan
Status: Recruiting
Contact: Fumihiko Kanai, Dr.
Gifu Municipal Hospital
Gifu, Japan
Status: Recruiting
Contact: Eiichi Tomita, Dr.
Hiroshima City Hospital
Hiroshima, Japan
Status: Recruiting
Contact: Yoshiyuki Kobayashi, Dr.
Hiroshima University Hospital
Hiroshima, Japan
Status: Recruiting
Contact: Hiroshi Aikata, Dr.
Kumamoto University Hospital
Kumamoto, Japan
Status: Recruiting
Contact: Yutaka Sasaki, Professor
Kyoto University Hospital
Kyoto, Japan
Status: Recruiting
Contact: Etsuro Hatano, Professor
Center for Gastroenterological and Hepatological Diseases
Miyazaki, Japan
Status: Recruiting
Contact: Hidemori Sakamoto, Dr.
Niigata University Medical and Dental Hospital
Niigata, Japan
Status: Recruiting
Contact: Kouhei Akazawa
Saiseikai Niigata Dai-ni Hospital
Niigata, Japan
Status: Recruiting
Contact: Toru Ishikawa, Dr.
Okayama University Hospital
Okayama, Japan
Status: Recruiting
Contact: Kazuhide Yamamoto, Professor
Osaka Red Cross Hospital
Osaka, Japan
Status: Recruiting
Contact: Ikuo Osaki, Dr.
The University of Tokushima Faculty of Medicine
Tokushima, Japan
Status: Recruiting
Contact: Tetsuji Takayama, Dr.
Kyoundo Hospital
Tokyo, Japan
Status: Recruiting
Contact: Shuntaro Obi, Dr.
National Cancer Center Hospital
Tokyo, Japan
Status: Recruiting
Contact: Takushi Okusaka, Dr.
Start Date
October 2010
Completion Date
September 2013
Sponsors
Ministry of Health, Labour and Welfare, Japan
Source
Ministry of Health, Labour and Welfare, Japan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page