UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055721 |
|---|---|
| Receipt number | R000062742 |
| Scientific Title | A retrospective study of stromal Caveolin-1 expression and efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma(WJOG18824G) |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2025/11/17 09:18:21 |
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Basic information
Public title
A retrospective study of stromal Caveolin-1 expression and efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma(WJOG18824G)
Acronym
CAPPUCCINO study
Scientific Title
A retrospective study of stromal Caveolin-1 expression and efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma(WJOG18824G)
Scientific Title:Acronym
CAPPUCCINO study
Region
| Japan |
Condition
Condition
Unresectable advanced gastric and esophagogastric junction adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the association of Caveolin-1 expression in tumor stroma and efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of Nanoparticle albumin-bound paclitaxel plus Ramucirumab in Caveolin-1 high-expressing (3+) and low-expressing (<3+) groups
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
1) Patients who have given consent to participate in this study.
2) Histologically diagnosed gastric or esophagogastric adenocarcinoma.
3) Unresectable or recurrent.
4) Patients who were older than 18 years of age at the initiation of Nanoparticle albumin-bound paclitaxel plus Ramucirumab or Paclitaxel plus Ramucirumab.
5) ECOG performance status (PS) 0, 1, or 2 at initiation of Nanoparticle albumin-bound paclitaxel plus Ramucirumab or Paclitaxel plus Ramucirumab.
6) Patients who have initiated Nanoparticle albumin-bound paclitaxel plus Ramucirumab or Paclitaxel plus Ramucirumab between January 1st, 2018 and December 31th, 2023.
7) Endoscopic biopsy tissue or surgical specimen obtained at prior to the initial chemotherapy can be provided.
Key exclusion criteria
1) Patients who have other active malignancies at the time of initiation of Nanoparticle albumin-bound paclitaxel plus Ramucirumab or Paclitaxel plus Ramucirumab. However, carcinoma in situ and intramucosal carcinoma that are considered curable by local therapy are not included in the active malignancies.
2) Prior palliative chemotherapy with taxanes prior to Nanoparticle albumin-bound paclitaxel plus Ramucirumab or Paclitaxel plus Ramucirumab. However, taxanes used as adjuvant chemotherapy are eligible.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenro |
| Middle name | |
| Last name | Hirata |
Organization
Keio University School of Medicine
Division name
Cancer center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3288
kenro@keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 10 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Caveolin-1 is a protein involved in the endogenous albumin transport pathway and is thought to facilitate the transport of Nanoparticle albumin-bound paclitaxel through vascular endothelial cell to tumor stroma. We hypothesized that the efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma would be stratified by the Caveolin-1 expression in tumor stroma. In this study, we will investigate the association of Caveolin-1 expression in tumor stroma and efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab for unresectable advanced gastric and esophagogastric junction adenocarcinoma. We will also compare the efficacy of Nanoparticle albumin-bound paclitaxel plus Ramucirumab with Paclitaxel plus Ramucirumab according to Caveolin-1 expression in tumor stroma.
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062742
