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This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.
The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy |
| |
| Control group | PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 Inhibitors | Drug | Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The objective response rate at 6 months | 6 months |
| Adverse events | Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The overall survival rate at 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | The duration of response at 2-year | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomin Fu | Contact | +86037165587483 | fuxiaomin0880@126.com | |
| Xiaomin Fu | Contact | +86037165587483 | zlyygql0855@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Quanli Gao | Henan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |