JRCT ID: jRCT1011200014
Registered date:10/12/2020
Early prediction of immune checkpoint inhibitor treatment efficacy in patients with untreated advanced non-small-cell lung cancer
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | non-small cell lung cancer |
Date of first enrollment | 10/12/2020 |
Target sample size | 22 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 18F-FDG PET/CT and liquid biopsy are performed 6 week after initiation of therapy with pembrolizumab |
Outcome(s)
Primary Outcome | To evaluate the discriminative power of the change of SUVmax, which is obtained via PET/CT 6 week after the initiation of pembrolizumab treatment. |
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Secondary Outcome | same analysis using liquid biopsy. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Previously untreated with chemotherapy 2. Patients more than 20 years old 3. Treated with pembrolizumab (combined with or without chemotherapy) 4. Appropriate physical status 5. Obtained informed consent |
Exclude criteria | 1. Small-cell carcinoma or unknown 2. Positive for EGFR mutation, ALK fusion, Ros-1 fusion, and BRAF mutation 3. Ever treated with chemotherapy or radiotherapy 4. Poor physical status 5. Severe complication 6. Fasting blood glucose over 150 mg/dl 7. Unable to perform 18F-FDG PET/CT or CT because of complications 8. Other inappropriate patients |
Related Information
Primary Sponsor | Takeuchi Satoshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Satoshi Takeuchi |
Address | Kita 15 Nishi 7, Kita-ku, Sapporo Hokkaido Japan 060-8638 |
Telephone | +81-11-706-5551 |
stakeuch@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Graduate School of Medicine |
Scientific contact | |
Name | Satoshi Takeuchi |
Address | Kita 15 Nishi 7, Kita-ku, Sapporo Hokkaido Japan 060-8638 |
Telephone | +81-11-706-5551 |
stakeuch@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Graduate School of Medicine |