UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056779 |
|---|---|
| Receipt number | R000064897 |
| Scientific Title | A multicenter prospective observational study on the clinical outcomes of patients with biliary tract cancer treated by systemic chemotherapy in combination with immune checkpoint inhibitors |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/01/22 09:34:11 |
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Basic information
Public title
A multicenter prospective observational study on the clinical outcomes of patients with biliary tract cancer treated by systemic chemotherapy in combination with immune checkpoint inhibitors
Acronym
An observational study on systemic chemotherapy with ICI for biliary cancer
Scientific Title
A multicenter prospective observational study on the clinical outcomes of patients with biliary tract cancer treated by systemic chemotherapy in combination with immune checkpoint inhibitors
Scientific Title:Acronym
An observational study on systemic chemotherapy with ICI for biliary cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This multicenter prospective observational study aims to evaluate real-world data on the therapeutic efficacy, the factors associated with treatment outcomes and the immune-related adverse events (irAEs) of systemic therapy in combination with immune checkpoint inhibitors (ICIs) for biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the efficacy of Gem + CDDP in combination with durvalumab or pembrolizumab and investigate the factors associated with treatment outcomes
To investigate the frequency and the characteristics of immune related adverse events
Key secondary outcomes
1) To investigate the frequency of genetic test in biliary tract cancer and its impact on treatment efficacy
2) To evaluate the treatment efficacy and safety by regimen in second-line and later-line therapies
3) To investigate the frequency and the characteristics of the adverse events other than irAEs
4) To investigate the factors associated with the occurrence of irAEs
5) To investigate the correlation between the occurrence of irAEs and survival.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with unresectable biliary tract cancer, including intrahepatic cholangiocarcinoma, hilar bile duct cancer, and distal bile duct cancer, gallbladder cancer or ampullary cancer.
2) Pathologically confirmed as adenocarcinoma or adenosquamous carcinoma. In cases of postoperative recurrence, if the surgical specimen already provided a pathological diagnosis, the pathological diagnosis for the recurrent lesion is not required.
3) Received no prior chemotherapy for biliary tract cancer. The patients who were treated with S-1 as postoperative adjuvant chemotherapy remain eligible.
4) Received no prior history of radiotherapy for biliary tract cancer. The patients who have received palliative radiation for bone metastases for pain control remain eligible.
5) Over 20 years old
6) Provided written informed consent to participate in this study.
Key exclusion criteria
1) With a malignancy of other organ that could influence prognosis.
2) Received any chemotherapy for other malignancy at the time of enrollment.
3) Received prior treatment with ICIs including of antiPD1, antiPDL1, antiPDL2 or antiCTLA4 antibodies, therapy of Tcell regulatory antibodies or vaccine therapy.
4) Judged to be unsuitable for the participant this study by investigator or sub-investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
2-2, yamadaoka, suita, osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Shigekawa |
Organization
Osaka University Graduate School of medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
2-2, yamadaoka, suita, osaka
TEL
06-6879-3621
Homepage URL
m-shigekawa@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Pancreas Forum
Institute
Department
Personal name
Funding Source
Organization
Dept. of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan
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
Ethical Review Board Osaka University Hospital
Address
2-2, yamadaoka, suita, osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2025 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064897
