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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03254004
Other study ID # 2017-08-032
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 8, 2018
Est. completion date November 30, 2021

Study information

Verified date December 2020
Source Samsung Medical Center
Contact jhingook Kim, MD
Phone 82-10-9933-3483
Email jhingookkim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200 mg every 3 weeks


Description:

This is a single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Patients will be treated with pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.


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Study Design


Intervention

Drug:
Pembrolizumab
pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.

Locations

Country Name City State
Korea, Republic of Samsung medical centre Seoul Kangnam

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the improvement of disease-free survival rate by adjuvant therapy with pembrolizumab for solid or micropapillary adenocarcinoma with pathologic stage I and tumor size no more than 4 cm. RECIST V1.1 up to 16 times. (screening, every 4 cycles during the study, every 3 months till 1 year since the study treatment, and then every 4 months afterward till 2 years and thereafter every 6 months till 3 years)
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