Real World Study of Four PD-1 Agents in China

• Conditions: Thoracic Cancer; Gynecologic Cancer; Abdomen Tumors; Malignant Melanoma
• Interventions: Drug: Chemotherapy

• Registration Number: NCT03966456
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

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 Timeline

• Study Start: 2018-06-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-26
• Last Update Submitted: 2019-05-26
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Primary Completion: 2021-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nivolumab	Chemotherapy	Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.
sintilimab	Chemotherapy	Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.
pembrolizumab	Chemotherapy	Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.
toripalimab	Chemotherapy	Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China