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The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)
Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor. Immunotherapy was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABR+Sintilimab | Experimental | Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. Sintilimab was used 2 weeks after the end of SABR. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablation Radiotherapy | Radiation | Stereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。 |
| Measure | Description | Time Frame |
|---|---|---|
| abscopal effect rate | A reaction produced following irradiation but occurring outside the zone of actual radiation absorption | at the time point of 3 Months after completion of the combined treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | AE,according to NCI-CTCAE V4.03 and immune-related (ir) RECIST | up to approximately 1 year |
| Progression-Free Survival (PFS) | PFS, defined as the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. |
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Inclusion Criteria:
1.The diagnostic criteria for early sMPLC refer to the American College of Chest Physicians (ACCP) standard, and the following conditions should be met:
c. If there is only one pathologically confirmed lesion or two pathological types are identical, the following conditions need to be met:
2. At least two lesions were suitable for SABR treatment.
3. ECOG performance status 0-2.
4. Stable lab values: Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
5. Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential.
6. Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deng Chong, MD | Contact | 8605922139531 | dengchongxm@163.com | |
| Jiang Jie, MD | Contact | 8605922137271 | jiangjiexm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang jie, MD | First affiliated Hospital of Xiamen University | Principal Investigator |
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| Sintilimab | Drug | Sintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles |
|
| up to approximately 1 year |
| Disease Control Rate (DCR) | Disease Control Rate(DCR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST | up to approximately 1 year |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
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