PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
|ClinicalTrials.gov Identifier: NCT03748901|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : June 7, 2019
This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC.
Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan.
PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.
|Condition or disease|
|Renal Cell Carcinoma|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients|
|Actual Study Start Date :||December 16, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Full analysis set
Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression
- Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients. [ Time Frame: Baseline ]Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
- Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3) [ Time Frame: Baseline ]Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
- Overall survival after nephrectomy (including cytoreductive nephrectomy) [ Time Frame: Baseline ]Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause.
- Time to recurrence after radical nephrectomy [ Time Frame: Baseline ]Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent.
- Treatment duration (first-line and second-line therapy) [ Time Frame: Baseline ]Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748901
|Aichi Medical University|
|Nagoya-city, Aichi, Japan, 480-1103|