UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016954 |
|---|---|
| Receipt number | R000019678 |
| Scientific Title | A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2023/11/08 14:38:45 |
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Basic information
Public title
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Acronym
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Scientific Title
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Scientific Title:Acronym
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of S-588410 as adjuvant therapy after curative resection in patients with esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the relapse-free survival in the S-588410 group with the placebo group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Relapse free survival
Key secondary outcomes
Specific CTL measurement, overall survival, disease-free survival, tumor evaluation, quality of life, assessment of AEs (CTCAE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-588410 will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for 94 weeks.
Interventions/Control_2
Placebo will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for 94 weeks.
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
1. Patients with thoracic esophageal squamous cell carcinoma after neoadjuvant therapy followed by curative resection.
2. Patients with lymph node metastasis positive histologically
3. HLA-A*24:02-positive patients
4. Patients who are male or female aged 20 years or older at the time of informed consent.
5. Patients with the ECOG PS 0 or 1 at enrollment.
6. Patients who provide a personally signed and dated informed consent document for participation in the study.
Key exclusion criteria
1. Patients who are expected to require anti-malignant tumor drug between enrollment and completion or discontinuation of the post-treatment period.
2. Patients with uncontrolled systemic or active infection.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Toshinobu |
| Middle name | |
| Last name | Iwasaki |
Organization
Shionogi & Co., Ltd.
Division name
Global Development Division
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
shionogiclintrials-admin@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kyokawa |
Organization
Shionogi & Co., Ltd.
Division name
Corporate Communications Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
Homepage URL
shionogiclintrials-admin@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
OncoTherapy Science, Inc.
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
Kindai University Hospital IRB
Address
377-2, Ohno-higashi, Osaka-Sayama, Osaka, Japan
Tel
072-366-0221
ck-jimu@med.kindai.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
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Not published
Publication of results
Published
Result
URL related to results and publications
https://site.convention.co.jp/77jes
Number of participants that the trial has enrolled
276
Results
The median time of relapse free survival (primary endpoint) was 84.3 weeks in the S-588410 group and 84.1 weeks in the placebo group (one-sided P value=0.8156, stratified weighted log-rank test with the Fleming-Harrington class of weights).
Results date posted
| 2023 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was conducted in HLA-A*24:02-positive patients with esophageal cancer after curative resection with neoadjuvant chemotherapy in whom lymph node metastases were confirmed.
Participant flow
A total of 276 participants were randomized to S-588410 group or placebo group (138 participants in each group).
Adverse events
Treatment-emergent adverse events (TEAEs) were reported in 98.6% of the S-588410 group and 96.3% of the placebo group. Most TEAEs were grade 3 or less and TEAEs with grade 4 or more were few in both groups. Frequent TEAEs were injection site reaction, nasopharyngitis, pyrexia, diarrhoea, back pain, and anastomotic stenosis; and these TEAEs were approximately comparable between groups. No new notable safety concerns about S-588410 were found in the study.
Outcome measures
Median time of relapse free survival (90% confidence interval) was 84.3 weeks (48.3, 119.6) in the S-588410 group and 84.1 weeks (48.1, not reached) in the placebo group (one-sided P value=0.8156, stratified weighted log-rank test with the Fleming-Harrington class of weights).
Median time of overall survival (90% confidence interval) was 236.3 weeks (183.7, not reached) in the S-588410 group and not reached in the placebo group (177.6, not reached)(one-sided P value=0.6533, stratified weighted log-rank test with the Fleming-Harrington class of weights).
Median time of disease-free survival (90% confidence interval) was 83.3 weeks (47.1, 118.1) in the S-588410 group and 72.1 weeks (47.1, 163.9) in the placebo group (one-sided P value=0.3621, stratified weighted log-rank test with the Fleming-Harrington class of weights).
For specific CTL measurement, the proportion of participants who showed CTL induction to at least one of the antigens for the initial 12 weeks after initial dose in the S-588410 group was 98.5%.
For quality of life, no clinically significant changes in each scale were found based on EORTC QLQ-C30, EQ-5D-5L, and EQ VAS.
Plan to share IPD
Not determined
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019678
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