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

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Anti-PD-1/PD-L1 antibodies

• Registration Number: NCT03787953
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-27
• Study Start: 2018-12-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-PD-1/PD-L1 antibodies	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China