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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This is a phase II clinical trial of SHR-1210 (an anti-PD-1 Inhibitor) simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.
It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 +Hypofraction radiotherapy | Experimental | SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant toxicity | above grade 3 AEs | First cycle (28 days) |
| 6-month-PFS | 6-month-progression free survival rate | From the start of treatment to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last SHR-1210 dose |
| PFS | Progression-Free-Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JINGMIN YU, PhD | Contact | 8613806406293 | 8653187984729 | jn7984729@public.jn.sd.cn |
| LIGANG XING, PhD | Contact | 8618053100188 | 8653167626819 | xinglg@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| JINGMIN YU, PhD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | 250117 | China |
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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 |
|---|---|
| C000631724 | camrelizumab |
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SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
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| up to 2 years |
| ORR | Objective Response Rate | At baseline,at the time point of every 8 weeks |
| DCR | Disease Control Rate | at the time point of every 8 weeks |
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |