Real World Study of Four PD-1 Agents in China

Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Thoracic Cancer; Malignant Melanoma; Abdomen Tumors
• Intervention / Treatment: Drug: Chemotherapy

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Xiaochun Zhang, Dr; Phone Number: +86-532-82915333; Email: jasmanouc@163.com
• Study Contact Backup: Name: Man Jiang, Dr; Phone Number: +86-532-82915333; Email: jm_ouc@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Xiaochun Zhang, Dr; Phone Number: +86-532-82915333; Email: jasmanouc@163.com
      • Sub-Investigator: Man Jiang, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
nivolumab; Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.	Drug: Chemotherapy; compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.; Other Names: targeting therapy
pembrolizumab; Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.	Drug: Chemotherapy; compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.; Other Names: targeting therapy
toripalimab; Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.	Drug: Chemotherapy; compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.; Other Names: targeting therapy
sintilimab; Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.	Drug: Chemotherapy; compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.; Other Names: targeting therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events (AEs)	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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.	2 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Xiaochun Zhang, Dr, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: Ic-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD only shared in the study group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No