UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056051 |
|---|---|
| Receipt number | R000064046 |
| Scientific Title | Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/12/02 10:33:15 |
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Basic information
Public title
Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial
Acronym
Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial
Scientific Title
Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial
Scientific Title:Acronym
Immune Checkpoint Inhibitors Plus Chemotherapy and Radiation/Chemoradiation Therapy Followed by Immune Checkpoint inhibitors Plus Chemotherapy for First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma with Dysphagia:A Pragmatic, Randomized, Phase II Trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of immune checkpoint inhibitor combination chemotherapy or immune checkpoint inhibitor combination chemotherapy after palliative radiotherapy/chemoradiotherapy in patients with unresectable esophageal cancer with passage obstruction and distant metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of improvement in obstruction of the passage of blood (DS score of 1 or more) at 9 weeks after the start of protocol treatment
Key secondary outcomes
Rate of improvement in obstruction during protocol treatment period
Period until passing obstruction is improved
Dysphagia Progression-free survival
Overall survival
Progression-free survival
Time to treatment failure
Objective response rate
Disease control rate
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FP plus ICI
Interventions/Control_2
RT plus minus FP to FP plus ICI
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.Histologically, the patient was diagnosed with squamous cell carcinoma of the esophagus (including the esophagogastric junction).
2.The patient has been diagnosed with stage IVB esophageal cancer (recurrent cases not included) that has distant metastasis and is not curatively resectable.
3.Patients with dysphagia score (DS 2-4). However, DS 4 cases are limited to those who are judged to be able to take oral medication by a method other than oral administration, such as a gastrostomy.
4.No prior chemotherapy or radiation therapy for esophageal cancer.
5.18 years of age or older at the time of obtaining informed consent.
6.ECOG performance status (PS) of 0 to 2.
7.Doctor in charge has determined that protocol treatment is safe
8.The contents of this study were fully explained to the participants, and written consent was obtained.
Key exclusion criteria
1.History of hypersensitivity to the components of 5-FU, cisplatin, nivolumab, or pembrolizumab.
2.No active overlapping cancers. However, early cancers such as superficial esophageal cancer and superficial head and neck cancer that are not considered to determine prognosis, and lesions equivalent to intraepithelial or intramucosal cancer that are considered to be cured by local treatment are acceptable.
3.pregnant or possibly pregnant
4.Doctor in charge has determined that the patient is inappropriate to participate in the study.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nagata |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
yusuke.nagata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nagata |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
yusuke.nagata@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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
| 2024 | Year | 11 | Month | 05 | 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
| 2024 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064046
