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NCT Number: NCT03748901

PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Medical University

Nagoya, Aichi-ken, 480-1103, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2018
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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