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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an openlabel，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 and chemotherapy in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 + Chemotherapy + Radiotherapy | Experimental | Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes. Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles. Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE), Serious Adverse Event(SAE) Adverse events | Incidence of Treatment-Emergent Adverse Events | Through study completion, an average of half a year] |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Through study completion, an average of 1 year |
| PFS | Progression-Free Survival | 1year and 3years |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
Subjects with any active autoimmune disease or history of autoimmune disease
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Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
Received a live vaccine within 4 weeks of the first dose of study medication.
Pregnancy or breast feeding.
Decision of unsuitableness by principal investigator or physician-incharge.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37275884 | Derived | Yan C, Huang H, Zheng Z, Ma X, Zhao G, Zhang T, Chen X, Cao F, Wei H, Dong J, Tang P, Jiang H, Wang M, Wang P, Pang Q, Zhang W. Spatial distribution of tumor-infiltrating T cells indicated immune response status under chemoradiotherapy plus PD-1 blockade in esophageal cancer. Front Immunol. 2023 May 19;14:1138054. doi: 10.3389/fimmu.2023.1138054. eCollection 2023. | |
| 35046943 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000711728 | spartalizumab |
| D050397 | Radiotherapy, Intensity-Modulated |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| IMRT or VMAT | Radiation | The IMRT or VMAT technique was used in our study. |
|
| Apatinib | Drug | Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2. |
|
| OS | overall survival | 1year and 3years |
| Ma X, Guo Z, Wei X, Zhao G, Han D, Zhang T, Chen X, Cao F, Dong J, Zhao L, Yuan Z, Wang P, Pang Q, Yan C, Zhang W. Spatial Distribution and Predictive Significance of Dendritic Cells and Macrophages in Esophageal Cancer Treated With Combined Chemoradiotherapy and PD-1 Blockade. Front Immunol. 2022 Jan 3;12:786429. doi: 10.3389/fimmu.2021.786429. eCollection 2021. |
| 34616588 | Derived | Zhang W, Yan C, Zhang T, Chen X, Dong J, Zhao J, Han D, Wang J, Zhao G, Cao F, Zhou D, Jiang H, Tang P, Zhao L, Yuan Z, Wang Q, Wang P, Pang Q. Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study. Oncoimmunology. 2021 Sep 28;10(1):1971418. doi: 10.1080/2162402X.2021.1971418. eCollection 2021. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |