UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049949 |
|---|---|
| Receipt number | R000056889 |
| Scientific Title | Effects of alkalization therapy for hepatocellular carcinoma: a retrospective study |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/12/31 10:40:01 |
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Basic information
Public title
Effects of alkalization therapy for hepatocellular carcinoma: a retrospective study
Acronym
Effects of alkalization therapy for hepatocellular carcinoma
Scientific Title
Effects of alkalization therapy for hepatocellular carcinoma: a retrospective study
Scientific Title:Acronym
Effects of alkalization therapy for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of alkalization therapy on patients with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS) from diagnosis
OS from the start of alkalization therapy
Urine pH before and after alkalization therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 91 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hepatocellular cancer who were treated at the Karasuma Wada Clinic between January 2013 and December 2020.
Patients who received alkalization therapy.
Patients who agreed written informed consent.
Key exclusion criteria
Patients who could not follow the alkalization therapy and/or visited our clinic less than 3 times.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Reo |
| Middle name | |
| Last name | Hamaguchi |
Organization
Japanese Society on Inflammation and Metabolism in Cancer
Division name
Japanese Society on Inflammation and Metabolism in Cancer, working group
Zip code
604-0842
Address
119 Nishioshikouji-cho, Higashinotouin-nishiiru, Oshikouji-street, Nakagyo-ku, Kyoto 604-0842, Japan
TEL
+81-75-223-3223
reo-h@nifty.com
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Hamaguchi |
Organization
Japanese Society on Inflammation and Metabolism in Cancer
Division name
Japanese Society on Inflammation and Metabolism in Cancer, working group
Zip code
604-0842
Address
119 Nishioshikouji-cho, Higashinotouin-nishiiru, Oshikouji-street, Nakagyo-ku, Kyoto 604-0842, Japan
TEL
+81-75-223-3223
Homepage URL
reo-h@nifty.com
Sponsor or person
Institute
Japanese Society on Inflammation and Metabolism in Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Society on Inflammation and Metabolism in Cancer
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japan-Multinational Trial Organization
Address
2-14-10-3F Marunouchi, Naka-ku, Nagoya, Aichi, Japan
Tel
052-218-3301
info@jmto.org
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
| 2023 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.scim.or.jp/wp/wp-content/uploads/2018/10/8926ff258bf85de6f409d8727c273d39.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1179049/full
Number of participants that the trial has enrolled
44
Results
The median OS from the start of alkalization therapy inpatients with a urine pH of >= 7.0 was not reached (n = 12, 95% CI = 3.0-not reached), which was significantly longer than that in patients with a pH of < 7.0(15.4 months, n = 17, 95% CI = 5.8-not reached, p < 0.05). The addition of alkalization therapy to standard therapies may beassociated with more favorable outcomes in HCC patients with increased urinepH after alkalization therapy.
Results date posted
| 2023 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In hepatocellular carcinoma (HCC) patients, is difficult to preventrecurrence even when remission is achieved. In addition, even with the advent ofdrugs that are effective for the treatment of HCC, a satisfactory extension ofpatient survival has not been achieved. To overcome this situation, wehypothesized that the combination of alkalization therapy with standardtreatments will improve the prognosis of HCC. We here report the clinicalresults of HCC patients treated with alkalization therapy at our clinic.
Participant flow
Patients with HCC treated at Karasuma Wada Clinic (in Kyoto, Japan), from January 1, 2013, to December 31, 2020 were analyzed.Overall survival (OS) from both the time of diagnosis and the start of alkalization therapy for each patient was compared. The mean urine pH was also calculated as a surrogate marker of tumor microenvironment pH, and OS from the start of alkalization therapy was compared between patients with a mean urine pH of >= 7.0 and those with a mean urine pH of < 7.0.
Adverse events
none
Outcome measures
The median OS from diagnosis was 95.6 months (95% confidence interval [CI] = 24.7-not reached), and from the start of alkalization therapy was 42.3 months (95%CI = 8.93-not reached). The median OS from the start of alkalization therapy inpatients with a urine pH of >= 7.0 was not reached (n = 12, 95% CI = 3.0-not reached), which was significantly longer than that in patients with a pH of < 7.0(15.4 months, n = 17, 95% CI = 5.8-not reached, p < 0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was retrospectively conducted to investigate the effects of alkalization therapy in patients with hepatocellular carcinoma. Currently, data analysis is in progress.
In addition, this study is comprehensively included in "Investigation for survival factors of cancer patients analyzed by the data science method" approved by IRB of the JMTO.
Management information
Registered date
| 2022 | Year | 12 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056889
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