Real World Study of Four PD-1 Agents in China

Study Overview
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Brief Summary
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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
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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）

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

Conditions
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Thoracic Cancer, Gynecologic Cancer, Abdomen Tumors, Malignant Melanoma

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nivolumab<br>Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy. | Drug: Chemotherapy<br>* compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.<br>* Other names: targeting therapy;|
| pembrolizumab<br>Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy. | Drug: Chemotherapy<br>* compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.<br>* Other names: targeting therapy;|
| toripalimab<br>Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy. | Drug: Chemotherapy<br>* compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.<br>* Other names: targeting therapy;|
| sintilimab<br>Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy. | Drug: Chemotherapy<br>* compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.<br>* Other names: targeting therapy;|

What is the study measuring?
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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 |