PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

Completed

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT03748901
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Study Start: 2018-12-16
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients.	Baseline	Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)	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)	Baseline	Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause.
Time to recurrence after radical nephrectomy	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)	Baseline	Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment.

Trial Locations

Locations (1)

Aichi Medical University; 🇯🇵 Nagoya-city, Aichi, Japan