A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors

Overview

The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for the treatment of advanced solid tumors.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 30, 2019

Detailed Description

The study is a real-world study and the case records of patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to analyze the effectivity and safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced solid tumors.

Interventions

  • Drug: Anti-PD-1/PD-L1 antibodies
    • The study is a real-world study. According to the actual medical history of patients, the usage of anti-PD-1/PD-L1 antibodies was collected.

Arms, Groups and Cohorts

  • Anti-PD-1/PD-L1 antibodies
    • Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy

Clinical Trial Outcome Measures

Primary Measures

  • Progression-free survival (PFS)
    • Time Frame: 6 months
    • PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.

Secondary Measures

  • Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy.
    • Time Frame: up to 4 weeks after the last dose
    • AEs/SAEs were evaluated using NCI-CTCAE v5.0
  • Objective Response Rate (ORR)
    • Time Frame: 6 months
    • ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).
  • Disease Control Rate (DCR)
    • Time Frame: 6 months
    • DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).
  • Overall survival (OS)
    • Time Frame: up to 12 months
    • OS was defined as the length of time from the administration of the first-dose until death from any cause.

Participating in This Clinical Trial

Inclusion Criteria

  • Pathologically or cytologically confirmed advanced solid tumors;
  • Received anti-PD-1/PD-L1 antibody therapy.

Exclusion Criteria

  • No specific exclusion criteria in this real world study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Collaborator
    • LinkDoc Technology (Beijing) Co. Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiao Zhao, Principal Investigator – Chinese PLA General Hospital
  • Overall Official(s)
    • Shunchang Jiao, PhD, Principal Investigator, Chinese PLA General Hospital
  • Overall Contact(s)
    • Xiao Zhao, PhD, +86-15210417668, rws2018@aliyun.com

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