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Real World Study of Four PD-1 Agents in China

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03966456
Collaborator
(none)
500
Enrollment
1
Location
60
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. ORR will be studied of the four PD-1 agents（nivolumab, pembrolizumab, toripalimab, sintilimab）

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
nivolumab

Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.

Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Names:
  • targeting therapy

    		•
    pembrolizumab

    Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy
    compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
    Other Names:
  • targeting therapy

    		•
    toripalimab

    Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy
    compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
    Other Names:
  • targeting therapy

    		•
    sintilimab

    Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy
    compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
    Other Names:
  • targeting therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [1 year]

      ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.

    Secondary Outcome Measures

    1. Number of Participants Experiencing Adverse Events (AEs) [1 year]

      Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment.

    Other Outcome Measures

    1. PFS [2 years]

      PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with lung cancer, liver cancer and other solid cancers

    • Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents

    • At least one measurable lesion

    • Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function

    Exclusion Criteria:
    • patients treated with PD-1 agents less than 2 terms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266000

    Sponsors and Collaborators

    • The Affiliated Hospital of Qingdao University

    Investigators

    • Principal Investigator: Xiaochun Zhang, Dr, The Affiliated Hospital of Qingdao University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    zhangxiaochun, Director of Cancer Precision Medical Center, The Affiliated Hospital of Qingdao University
    ClinicalTrials.gov Identifier:
    NCT03966456
    Other Study ID Numbers:
    • Ic-01
    First Posted:
    May 29, 2019
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of May 29, 2019