UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050765 |
|---|---|
| Receipt number | R000057848 |
| Scientific Title | Additional research to the "Phase II Nab-Paclitaxel + Ramucirumab + Nivolumab in Unresectable Advanced or Recurrent Gastric Cancer Refractory to First-Line Therapy Including Pyrimidine Fluoride, Platinum, and Anti-PD-1/PD-L1 Antibodies (PADDLE)" study |
| Date of disclosure of the study information | 2023/04/11 |
| Last modified on | 2023/04/04 19:29:53 |
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Basic information
Public title
Additional research to the "Phase II Nab-Paclitaxel + Ramucirumab + Nivolumab in Unresectable Advanced or Recurrent Gastric Cancer Refractory to First-Line Therapy Including Pyrimidine Fluoride, Platinum, and Anti-PD-1/PD-L1 Antibodies (PADDLE)" study
Acronym
Additional research to PADDLE study
Scientific Title
Additional research to the "Phase II Nab-Paclitaxel + Ramucirumab + Nivolumab in Unresectable Advanced or Recurrent Gastric Cancer Refractory to First-Line Therapy Including Pyrimidine Fluoride, Platinum, and Anti-PD-1/PD-L1 Antibodies (PADDLE)" study
Scientific Title:Acronym
Additional research to PADDLE study
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To comprehensively analyze the impact of nab-paclitaxel + ramucirumab + nivolumab on the anti-tumor immune response in gastric cancer using clinical specimens from patients treated with nab-paclitaxel + ramucirumab + nivolumab therapy to explore predictors of efficacy and resistance mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of drug therapy on immune profiling and gene expression in tumor tissue or peripheral blood, and their interrelationship with therapeutic effects
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable advanced or gastric cancer who participated in the PADDLE study
Key exclusion criteria
None
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shoji |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
hshouji@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Hirano |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
Homepage URL
hihirano@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2023 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tumor tissue samples and peripheral blood samples collected for this additional study that will be collected and stored in the PADDLE study will be used for 1) gene mutation and expression analysis (DNA and RNA), 2) immune cell phenotyping, 3) blood fluid factor analysis, and 4) histopathologic analysis to analyze their association with the efficacy of nab-paclitaxel + ramucirumab + nivolumab therapy.
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057848
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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