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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787953
• Other study ID #: PDL1-2018-301BJ
• Status: Recruiting
• Start date: December 30, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: May 2019
• Source: Chinese PLA General Hospital
• Contact: Xiao Zhao, PhD
• Phone: +86-15210417668
• Email: rws2018[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, KRAS mutation, TMB and MSI	before the first dose
Primary	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	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
Secondary	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
Secondary	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
Secondary	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