Real World Study of Four PD-1 Agents in China

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966456
• Other study ID #: Ic-01
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2019
• Source: The Affiliated Hospital of Qingdao University
• Contact: Xiaochun Zhang, Dr
• Phone: +86-532-82915333
• Email: jasmanouc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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）

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdomen Tumors
• Abdominal Neoplasms
• Gynecologic Cancer
• Malignant Melanoma
• Melanoma
• Thoracic Cancer

Intervention

Drug:
• Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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