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This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR 1701+radiotherapy | Experimental | SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1701 | Drug | PD-L1 / TGF-β RII double antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing adverse event (AE) | From the first administration of shr-1701 to 90 days after the last Administration | |
| Number of participants experiencing serious adverse event (SAE) | From the first administration of shr-1701 to 90 days after the last Administration |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | Up to approximately 24 months | |
| Objective Response Rate (ORR) | Up to approximately 24 months | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
The subjects had any history of autoimmune disease or active autoimmune disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JinMing Yu, PhD | Contact | 8613806406293 | 8653187984729 | jn7984729@public.jn.sd.cn |
| Name | Affiliation | Role |
|---|---|---|
| JinMing Yu, PhD | Shandong Cancer Hospital and Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
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| Up to approximately 24 months |
| Overall survival (OS) | Up to approximately 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |