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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nivolumab | Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy. |
| |
| pembrolizumab | Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy. |
| |
| toripalimab | Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy. |
| |
| sintilimab | Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochun Zhang, Dr | Contact | +86-532-82915333 | jasmanouc@163.com | |
| Man Jiang, Dr | Contact | +86-532-82915333 | jm_ouc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaochun Zhang, Dr | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
IPD only shared in the study group
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| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |