Unique ID issued by UMIN | UMIN000007267 |
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Receipt number | R000008575 |
Scientific Title | Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma |
Date of disclosure of the study information | 2012/02/11 |
Last modified on | 2022/08/23 01:18:39 |
Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Efficacy of HAIC with cisplatin before RFA for HCC
Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Efficacy of HAIC with cisplatin before RFA for HCC
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before RFA for the prevention of HCC recurrence
Efficacy
Phase III
Recurrence free survival
Incidence of adverse events
Time to treatment failure with RFA
Evaluation of treatment effect with tumor markers
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Placebo
YES
2
Treatment
Maneuver |
Hepatic arterial infusion chemotherapy with cisplatin and RFA
RFA
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities
2) Less than or equal to 3 lesions, 30 mm or less in diameter
3) No extra-hepatic metastasis
4) No vascular invasion
5) Patients in Child-Pugh Class A or B
6) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old
7) Patients with an ECOG Performance Status (PS) score of 0 or 1
8) No prior chemotherapy
9) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 8.5 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 2.0 mg/dL
e) AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
f) Cre<= within 1.5 times of normal limit
10) Written informed consent
11) Life expectancy of at least 6 months
1) Patients with histologically diagnosed mixed hepatocellular carcinoma or sarcomatoid carcinoma
2) History of any therapy to hepatocellular carcinoma
3) Patients unsuitable for RFA
4) Patients unsuitable for administration of CDDP
5) Patients who have simultaneous malignancies
6) Patients who have severe complications
7) Ascites or pleural effusion unresponsible to therapy
8) Patients inadequate in the investigator's judgement
90
1st name | Kazuhide |
Middle name | |
Last name | Yamamoto |
Okayama university graduate school of medicine, dentistry, and pharmaceutical sciences
Department of gastroenterology and hepatology
7008558
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture
090-235-7219
kazuhide@md.okayama-u.ac.jp
1st name | Kazuhiro |
Middle name | |
Last name | Nouso |
Okayama university hospital
Department of gastroenterology
7008558
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture
086-235-7219
nouso@cc.okayama-u.ac.jp
Okayama University Hospital
None
Self funding
Department of Gastroenterology, Okayama City Hospital, Okayama, Japan
Medical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima, Japan
Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan
Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan
Department of Internal Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan
Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan
Okayama university graduate school of medicine, dentistry, and pharmaceutical sciences, ethics committee
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture
086-235-6762
MAE6605@adm.okayama-u.ac.jp
NO
岡山大学病院(岡山県)
広島市民病院(広島県)
岡山市民病院(岡山県)
福山市民病院(広島県)
岡山赤十字病院(岡山県)
三豊総合病院(香川県)
2012 | Year | 02 | Month | 11 | Day |
https://pubmed.ncbi.nlm.nih.gov/33687130/
Published
https://pubmed.ncbi.nlm.nih.gov/33687130/
74
Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320-1.091; p = 0.094]. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).
2022 | Year | 08 | Month | 23 | Day |
2021 | Year | 03 | Month | 29 | Day |
Patients with naive early stage HCC diagnosed between August 2012 and July 2016 were recruited. All authors had access to the study data, and reviewed and approved the final manuscript.
After confirming the fulfillment of the eligibility criteria, the investigators registered the patients using a Web based system. The patients were then randomly assigned to receive either HAIC before RFA therapy (HAIC group) or RFA monotherapy (non HAIC group) in a 1 to 1 ratio. Allocation of the treatment group was performed with hos- pitals, tumor size, tumor number, and performance status as stratification factors. Patients were blinded to treatment allocation, although the investigators who conducted the HAIC therapy could not be blinded.
none
Progression free survival
Time to untreatable progression
Adverse events
Changes of tumor markers
Main results already published
2012 | Year | 01 | Month | 24 | Day |
2012 | Year | 01 | Month | 24 | Day |
2012 | Year | 03 | Month | 01 | Day |
2019 | Year | 07 | Month | 31 | Day |
2012 | Year | 02 | Month | 11 | Day |
2022 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008575
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