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

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ClinicalTrials.gov Identifier: NCT03787953
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
Xiao Zhao, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment
Advanced Solid Tumors Drug: Anti-PD-1/PD-L1 antibodies

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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).

  3. 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).

  4. 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.


Other Outcome Measures:
  1. Biomarkers [ Time Frame: before the first dose ]
    Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI


Biospecimen Retention:   Samples With DNA
Biopsy specimen or blood specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787953


Contacts
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Contact: Xiao Zhao, PhD +86-15210417668 rws2018@aliyun.com

Locations
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China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Xiao Zhao, PhD         
Principal Investigator: Shunchang Jiao, PhD         
Principal Investigator: Xiao Zhao, PhD         
Sponsors and Collaborators
Chinese PLA General Hospital
LinkDoc Technology (Beijing) Co. Ltd.
Investigators
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Principal Investigator: Shunchang Jiao, PhD Chinese PLA General Hospital

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Responsible Party: Xiao Zhao, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03787953     History of Changes
Other Study ID Numbers: PDL1-2018-301BJ
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiao Zhao, Chinese PLA General Hospital:
anti-PD-1/PD-L1 antibodies
Efficacy
Safety
Real world study

Additional relevant MeSH terms:
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Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs