Unique ID issued by UMIN | UMIN000015739 |
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Receipt number | R000018315 |
Scientific Title | The efficacy of HAIC in combination with sorafenib: multicenter, phase II study |
Date of disclosure of the study information | 2014/11/22 |
Last modified on | 2020/04/12 09:18:25 |
The efficacy of HAIC in combination with sorafenib: multicenter, phase II study
The efficacy of HAIC in combination with sorafenib.
The efficacy of HAIC in combination with sorafenib: multicenter, phase II study
The efficacy of HAIC in combination with sorafenib.
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Sorafenib is a useful molecular target drug for advanced hepatodellular carcinoma.However,the response rate is very low (0.6-3.3%). On the other hand, hepatic artery injection chemotherapy (HAIC) has higher response rate (8-71%) than sorafenib.In this study, we will evaluate the efficacy of HAIC in combination with sorafenib.
Efficacy
Adverse effect, QOL, response rate, PFS, OS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Sorafenib is administered orally 400 mg(2 x 200 mg) once or twice daily.The regimen of HAIC contains platinum,fluorouracil,epirubicin or mitomycin C. HAIC is repeated every 4 to 6 weeks.
20 | years-old | <= |
100 | years-old | >= |
Male and Female
Patients with advanced hepatocellular carcinoma who has already administerd sorafenib at least 4 weeks.
Patients with large volume ascites, brain metastases, hypertension (diastric pressure is over 100mmHg), uncontrorable cardiac problems, sever renal failure, active infection (without viral hepatitis), active gastric bleeding, cancer in other organ, hepatic encepharopathy, and sever drug allergy. Pregnant or lactating women, and the women who wish to be pregnant. Patients who have difficulty in oral feeding.
20
1st name | Takaaki |
Middle name | |
Last name | Sugihara |
Tottori University Faculty of Medicine
Department of gastroenterology
6838504
36-1 Nishimachi, Yonago, Tottori prefecture
0859-38-6527
sugitaka@med.tottori-u.ac.jp
1st name | Takaaki |
Middle name | |
Last name | Sugihara |
Tottori University Faculty of Medicine
Department of gastroenterology
6838504
36-1 Nishimachi, Yonago, Tottori prefecture
0859-38-6527
sugitaka@med.tottori-u.ac.jp
Tottori University Faculty of Medicine
No organization.
Self funding
Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital
36-1 Nishimachi, Yonago, Tottori prefecture
0859386946
crsc@ml.med.tottori-u.ac.jp
NO
2014 | Year | 11 | Month | 22 | Day |
Unpublished
Terminated
2014 | Year | 11 | Month | 21 | Day |
2014 | Year | 11 | Month | 21 | Day |
2014 | Year | 11 | Month | 25 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2014 | Year | 11 | Month | 22 | Day |
2020 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018315
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