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This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy. |
|
| Arm B | Placebo Comparator | Placebo + Paclitaxel + Cisplatin + Radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by IRC | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigators | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years |
| OS | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier. |
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Inclusion Criteria:
1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
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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 |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel |
| Drug |
IV infusion |
|
| Cisplatin | Drug | IV infusion |
|
| Placebo | Drug | IV infusion |
|
| Radiation | Radiation | Concurrent Radiation |
|
| up to 3 years |
| ORR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years |
| DoR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 3 years |
| AE | adverse events | up to 3 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |