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The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with PMBCL. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined anti-PD-1 and R-CHOP | Drug | Sintilimab,200mg, d1, intravenous drip; Rituximab,375mg/㎡, d1,intravenous drip; Cyclophosphamide,750mg/㎡,d2,intravenous drip; Doxorubicin,50mg/㎡ (or Liposome doxorubicin ,40 mg/㎡),d2,intravenous drip; Vincristine,1.4mg/㎡, d2(Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission (CR) | 2years | |
| overall response rate (ORR) | The proportion of patients with a PR and CR | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date | 2 years |
| progression survival (PFS) | The time from enrollment until tumor progression or death from any cause, whichever occurred first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Wang, MD | Contact | +86-15920352412 | wagnhua@sysucc.org.cn |
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|
| 2 years |
| bio-marker analysis | Correlation between programmed death-ligand 1 expression and efficacy | 2 years |