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

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 Overview

• Status: Unknown
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Xiao Zhao, PhD; Phone Number: +86-15210417668; Email: rws2018@aliyun.com

Study Locations

• China
  • Beijing, China, 100853
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Xiao Zhao, PhD
    • Principal Investigator: Shunchang Jiao, PhD
    • Principal Investigator: Xiao Zhao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy.	AEs/SAEs were evaluated using NCI-CTCAE v5.0	up to 4 weeks after the last dose
Objective Response Rate (ORR)	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).	6 months
Disease Control Rate (DCR)	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).	6 months
Overall survival (OS)	OS was defined as the length of time from the administration of the first-dose until death from any cause.	up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI	before the first dose

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Shunchang Jiao, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2018
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (ACTUAL): December 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Real world study; anti-PD-1/PD-L1 antibodies
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: PDL1-2018-301BJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No