PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

NCT ID: NCT03748901

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

830 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-16

Study Completion Date

2021-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aichi Medical University

Nagoya, Aichi-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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CMA-Ate004

Identifier Type: -

Identifier Source: org_study_id

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