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The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan liposome plus SHR1316 plus fluorouracil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposome | Drug | Irinotecan liposome intravenous infusion will be administered during the first day of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-Free Survival (PFS) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| Objective Response Rate(ORR) | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
Prior therapy as follow:
Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
Subjects with any active autoimmune disease or history of autoimmune disease;
Pregnancy or breast feeding;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Shi | Contact | +86-18036618733 | hrshifei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Huang | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital,Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| SHR-1316 | Drug | SHR-1316 intravenous infusion will be administered during the first day of treatment. |
|
| Fluorouracil | Drug | Fluorouracil intravenous infusion will be administered during the first day of treatment. |
|
| approximately 22 months |
| Overall Survival(OS) | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. | approximately 22 months |
| Adverse Events(AE) | adverse events | approximately 22 months |
| D006571 |
| Heterocyclic Compounds |