UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061966 |
|---|---|
| Receipt number | R000070908 |
| Scientific Title | Adjusted Real-World Effectiveness of Existing Therapies for Advanced/Metastatic, Unresectable KRAS G12C-Mutated Pancreatic Cancer in Japan |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/18 19:51:17 |
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Basic information
Public title
Real-world effectiveness of existing therapies in patients with pancreatic cancer in Japan using genomic data
Acronym
Effectiveness of existing therapies with pancreatic cancer
Scientific Title
Adjusted Real-World Effectiveness of Existing Therapies for Advanced/Metastatic, Unresectable KRAS G12C-Mutated Pancreatic Cancer in Japan
Scientific Title:Acronym
Effectiveness of existing therapies with KRAS G12C pancreatic cancer
Region
| Japan |
Condition
Condition
Advanced/metastatic pancreatic ductal adenocarcinoma (PDAC)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effectiveness of existing therapies using objective response rate (ORR) in a C-CAT cohort adjusted to match baseline characteristics of the JZQA trial cohort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective Response Rate (ORR)
Key secondary outcomes
BOR, DCR, PFS, OS
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- KRAS G12C-mutated advanced/metastatic pancreatic cancer
- Patients receiving second-line or later therapy
- ECOG Performance Status 0-1
- Age >=18 years
Key exclusion criteria
- Multiple primary cancers
- Missing key variables required for adjustment
- No tumor response assessment after second-line treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makiuchi |
| Middle name | |
| Last name | Takeshi |
Organization
Eli Lilly Japan
Division name
Japan Drug Development and Medical Affairs
Zip code
651-0086
Address
5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan
TEL
078-242-9000
makiuchi_takeshi@lilly.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Nakano |
Organization
Eli Lilly Japan
Division name
Japan Drug Development and Medical Affairs
Zip code
651-0086
Address
5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan
TEL
080-3529-7226
Homepage URL
nakano_noriko@network.lilly.com
Sponsor or person
Institute
Eli Lilly Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS
Address
2nd Floor, ST Shibuya Building, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo 150-0043, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2026 | Year | 06 | Month | 30 | 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
| 2026 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070908
