Clinical trial · Observational
PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Full analysis set
- description
- 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
Primary outcomes (1)
- measure
- Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients.
- timeFrame
- Baseline
- description
- Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
Secondary outcomes (4)
- measure
- Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)
- timeFrame
- Baseline
- description
- Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research. * 2\. Age at nephrectomy≧20 years * 3.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 Exclusion Criteria: * 1\. Malignancies other than RCC is co-existed from the time of nephrectomy and death. * 2\. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.
References
Publications (0)
Data not yet available