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A single-center,prospective interventional study to explore the efficacy of PD-1 antibody Sintilimab on early-stage multiple primary lung cancer patients with ground-glass nodules in CT scan.
This study is a single-center,prospective interventional clinical study, all subjects enrolled are multiple primary lung cancer patients with ground-glass density in CT scan.The samples plan for the study was 36 cases.The enrolled patients will receive intravenous infusion of Sintilimab 200mg every 3 weeks up to 4 cycles, and the efficacy will be evaluated after cycle 2 and 4 using RECIST criteria (version 1.1 ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Antibody Sintilimab | Experimental | Patients receive the treatment of PD-1 antibody Sintilimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody Sintilimab | Drug | Patients in experimental group receive the treatment of PD-1 antibody Sintilimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR of target lesions. | The objective response rate will be evaluated after 4 courses of treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The safty of PD-1 Antibody Sintilimab | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxing He, MD | Contact | +86-02-83062808 | hejx@vip.163.com | |
| Wenhua Liang, PhD | Contact | +86-02-83062808 | liangwh1987@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He, MD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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Clinical trials with a single arm
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