Search for predictors of immune checkpoint inhibitors in MSI-High cancer patients.
- Conditions
- MSI-High cancer
- Registration Number
- JPRN-jRCT1030210039
- Lead Sponsor
- akamura Yoichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Patients with unresectable advanced/recurrent malignant pleural mesothelioma who have indication for treatment with immune checkpoint inhibitors and have measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) Ver1.1.
2. Patients who are 20 years of age or older at the time of obtaining informed consent.
3. Patients who have received sufficient explanation before participating in this study, and who have obtained sufficient understanding and voluntary written informed consent of the patient. Patients who lack the ability to consent are not included.
1. Hepatitis B virus: HBs antigen or hepatitis C virus: HCV-RNA positive patients.
2. Patients with a positive human immunodeficiency virus (HIV) test.
3. Patients judged by the principal investigator or coordinator to be inappropriate as research subjects.
4. Patients who have received other immune checkpoint inhibitors, previously.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint<br>The primary endpoint is the detection of immune complexes that correlate with the effects of immune checkpoint inhibitors. We plan to collect samples up to 4 times for each patient.<br>1) Samples can be collected 3 times or more.<br>2) It was possible to qualitatively and quantify immune complexes in the collected samples.<br>Patients who have achieved the above 1) and 2) are defined as events.
- Secondary Outcome Measures
Name Time Method Response Rate:RR<br>Progression free survival:PFS<br>Overall survival:OS<br>Number of immune complexes in serum in each case.