UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005805 |
|---|---|
| Receipt number | R000006868 |
| Scientific Title | Pilot study of intraarterial interferon/CDDP/5-fluorouracil combination chemotherapy for advanced hepatocellular carcinoma with translational research to predict efficacy |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2019/06/25 17:55:12 |
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Basic information
Public title
Pilot study of intraarterial interferon/CDDP/5-fluorouracil combination chemotherapy for advanced hepatocellular carcinoma with translational research to predict efficacy
Acronym
IFN/CDDP/5-FU for advanced HCC with translational research to predict efficacy
Scientific Title
Pilot study of intraarterial interferon/CDDP/5-fluorouracil combination chemotherapy for advanced hepatocellular carcinoma with translational research to predict efficacy
Scientific Title:Acronym
IFN/CDDP/5-FU for advanced HCC with translational research to predict efficacy
Region
| Japan |
Condition
Condition
Advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy and safety of intraarterial IFN/CDDP/5-FU chemotherapy for advanced hepatocellular carcinoma .
To conduct translational research to predict treatment efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Response rate, tumor control rate, safety, translational research
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraarterial IFN/CDDP/5-FU chemotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma
2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization.
3) Child-Pugh A or B
4) >=20 years old
5) ECOG Performance Status 0-2
6) oral intake is possible
7) any extrahepatic lesions
8) more than one measurable disease
9) Adequate baseline organ function:
neutrophil > 1,500/mm3, hemoglobin >=8.5g/dl, platelets > 75,000/mm3, serum bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <2.0mg/dL
10) written informed consent
Key exclusion criteria
1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change
2) previous therapy for hepatocellular carcinoma within 30 days
3) preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy)
4) inadequate for administration of interferon, 5-FU or cisplatin
5) active double cancer
6) severe complication
7) refractory ascites or pleural effusion
8) inappropriate for entry onto this study in the judgment of the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Nakamoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
910-1193
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-3111
nakamoto-med2@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Nemoto |
| Middle name | |
| Last name | Tomoyuki |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
910-1193
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-3111
Homepage URL
nemotot@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui, Crinical Trial and Advanced Medical Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
Tel
0776-61-3111
watanabe@u-fukui.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4179816/pdf/mco-02-06-1028.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4179816/pdf/mco-02-06-1028.pdf
Number of participants that the trial has enrolled
12
Results
The response rate was significantly higher in patients treated with HAIC (37.5%) compared to that in patients treated with sorafenib (no response). The median overall survival (18.6 and 11.7 months) and progression-free survival (4.0 and 5.0 months) were similar between the sorafenib and HAIC groups, respectively. In the sorafenib group, 58.3% of the patients discontinued treatment compared to none in the HAIC group.
Results date posted
| 2019 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
Advanced HCC
Participant flow
We retrospectively analyzed data from elderly patients with advanced unresectable HCC, who were treated at our hospital between March, 2002 and June, 2013. Eligible patients included those aged 70 years and more with histologically or clinically confirmed advanced HCC. HCC was considered as unresectable in patients who presented with severe vascular invasion or multiple intrahepatic lesions (i.e., 5 and more nodules), or in those with progressive disease (PD) following surgical or locoregional therapy intervention. A total of 20 eligible patients were identified.
Adverse events
A total of 7 patients (58.3%) in the sorafenib group discontinued treatment due to grade 3 AEs [4 patients, anorexia; and 1 patient each with hand-foot (HF) syndrome, ascites and hepatic encephalopathy], whereas no patients demonstrated intolerance to HAIC. The discontinuation rate in the sorafenib group was significantly higher compared to that in the HAIC group (P=0.015). Among sorafenib-treated patients, the most frequent AEs were mild in severity (grade 1/2) and included HF syndrome, anorexia, hypoalbuminemia and diarrhea. Grade 3 AEs included HF syndrome, anorexia and hypertension. One Child-Pugh class A patient developed hepatic failure (hepatic encephalopathy) and sorafenib was discontinued. There were no grade 4 AEs. Among HAIC group patients, the most frequent AEs were mostly mild in severity (grade 1/2) and included decreased platelet count, anemia, fever, malaise, anorexia, hypoalbuminemia, decreased white blood cell count and decreased neutrophil count. In total, 6 hematological AEs of grade 3/4 were recorded in 4 patients. In the HAIC group, 1 patient (12.5%) experienced catheter occlusion as a catheter-related complication. In addition, 5 patients in the sorafenib group changed Child-Pugh class from A to B, whereas none of the patients in the HAIC group changed Child-Pugh class. These changes were mostly caused by the development of hypoalbuminemia in sorafenib-treated patients; there was no significant change in the prothrombin time-international normalized ratio (PT-INR).
Outcome measures
The mean daily dose and duration of sorafenib treatment were 544 mg and 5.3 months, respectively. The mean number of treatment cycles in the HAIC group was 1.8 (~2.2 months). The treatment responses are summarized in Table II. The RR was significantly different between the two groups, as patients in the sorafenib group failed to respond to treatment (P=0.049). However, there was no significant difference in TCR between the two groups. Two patients in the HAIC group achieved a sustained CR after receiving addi- tional RFA: one initially achieved a CR in response to HAIC and the other initially demonstrated a PR in response to HAIC.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006868
