UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053183 |
|---|---|
| Receipt number | R000060692 |
| Scientific Title | Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2023/12/20 23:18:18 |
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Basic information
Public title
Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia
Acronym
Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia
Scientific Title
Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia
Scientific Title:Acronym
Multicenter prospective observational study of immune checkpoint inhibitor based therapy in advanced esophageal cancer patients with dysphagia
Region
| Japan |
Condition
Condition
Advanced esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study aims to clarify the efficacy and safety of nivolumab/pembrolizumab + 5-FU + cisplatin, or nivolumab + ipilimumab therapy in unresectable esophageal cancer patients with dysphagia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of patients who have an improvement of dysphagia score and who can accommodate passage of an endoscope (endoscope with a diameter of 8.9-10.4 mm) at 8 weeks from the start of treatment.
Key secondary outcomes
1) Proportion of sustained efficacy at the primary site at 24 weeks
2) Proportion of primary tumor reduction equivalent to T1 within 24 weeks
3) Overall survival (OS) and the relationship between efficacy of primary tumor and OS
4) Overall response rate (ORR) and the relationship between efficacy of primary tumor and ORR
5) Progression-free survival (PFS)
6) Duration of sustained improvement in dysphagia score (Dysphagia PFS)
7) Proportion of patients weaned off supplemental nutrition
8) Proportion of patients receiving additional treatment for the primary tumor
9) Safety
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
) Histologically diagnosed with esophageal squamous cell carcinoma or adenosquamous carcinoma
2) Unresectable esophageal with primary tumor
3) Dysphagia with score of 1 or higher.
*Passability of upper gastrointestinal endoscopy is not a criterion
4) Age 20 or older
5) ECOG Performance Status (PS) of 0-2
6) Receives first-line treatment with checkpoint inhibitor combined chemotherapy (nivolumab + 5-FU + cisplatin, pembrolizumab + 5-FU + cisplatin), or nivolumab + ipilimumab therapy, with an expected treatment duration of at least 8 weeks
7) Written consent obtained
Key exclusion criteria
1) Expected prognosis of less than 3 months
2) History of receiving checkpoint inhibitor therapy
3) History of radiation therapy to the primary esophageal cancer, or planned concurrent chemoradiation therapy
4) Presence of uncontrollable comorbidities or serious complications
5) Presence of a mental disorder that makes it difficult to complete questionnaires
6) Considered unsuitable for enrollment in this study by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ando |
Organization
Toyama University Hospital
Division name
Third department of internal medicine
Zip code
930-0194
Address
Sugitani 2630, Toyama, Japan
TEL
+81-76-434-7301
takayuki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yurika |
| Middle name | |
| Last name | Nakayama |
Organization
Toyama University Hospital
Division name
Third department of internal medicine
Zip code
930-0194
Address
Sugitani 2630, Toyama, Japan
TEL
+81-76-434-7301
Homepage URL
yurika.pp0522@gmail.com
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyama Prefectural Central Hospital
JA Toyama Kouseiren Takaoka Hospital
University of Miyazaki Hospital
Ishikawa prefectural central hospital
Nagaoka Chuo General Hospita
Itoigawa General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
Sugitani 2630, Toyama, Japan
Tel
+81-76-415-8857
rinri@adm.u-toyama.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
| 2023 | Year | 12 | Month | 21 | 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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design; Prospective observational study
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060692
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