Unique ID issued by UMIN | UMIN000019344 |
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Receipt number | R000022371 |
Scientific Title | Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study |
Date of disclosure of the study information | 2015/11/01 |
Last modified on | 2020/10/18 09:23:48 |
Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study
Short-term HAIC using DSM for advanced HCC
Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study
Short-term HAIC using DSM for advanced HCC
Japan |
advanced hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
We investigate the safety and efficacy of arterial infusion chemotherapy using DSM for advanced hepatocellular carcinoma patients.
Safety
Safety
Response, Survival, Progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
HAIC with DSM
On day 1 and 7, cisplatin (50mg) is administered via the injection port. After that point, emulsion obtained by mixing DSM and contrast agent is injected until stasis and reflux are achieved. Subsequently, 5-fluorouracil (250 mg/body) injected continuously for 24hr from days 1 to 5 and days 8 to 12 using infuson pump.
The antitumor effect is assessed every 4 weeks by dynamic CT. In principle, the treatment course is repeated several times unless the tumor progressed during the therapy.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with advanced hepatocellular carcinoma
2) HCC without extrahepatic lesion
3) Patients who have no influence on previous treatment
4) Performance status(PS) 0 or 1
5) Child-Pugh A or B
6) Favorable function of major organs (bone marrow, kidney, heart), and meeting criteria as follows:
(1) WBC >= 2500/mm3
(2) platelet count>= 50000/mm3
(3) hemogrobin level >= 9.0g/dl
(4) total bilirubin <= 3.0mg/dl
(5) serum creatinine level < 2mg/dl
(6) BUN <= 25mg/dl
(7) prothrombin time activity >= 50%
7) age >= 20years, male and female
1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis)
2) Active double cancers
3) Past history of hypersensitivity for drugs including iodine and contrast agent
4) Patients with pregnancy, lactation or possibility of pregnancy
5) Chronic respiratory failure
6) No hypersensitivity to DSM
7) Patients who judged as inadequacy due to other reasons by the doctor
30
1st name | |
Middle name | |
Last name | Issei Saeki |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterology and Hepatology
1-1-1 Minamikogushi, Ube, Yamaguchi
0836-22-2241
issaeki@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Issei Saeki |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterology and Hepatology
1-1-1 Minamikogushi, Ube, Yamaguchi
0836-22-2241
issaeki@yamaguchi-u.ac.jp
Yamaguchi University Hospital
None
Self funding
NO
2015 | Year | 11 | Month | 01 | Day |
Unpublished
Terminated
2015 | Year | 08 | Month | 26 | Day |
2015 | Year | 08 | Month | 26 | Day |
2015 | Year | 11 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2015 | Year | 10 | Month | 14 | Day |
2020 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022371
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