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This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 + paclitaxel + cisplatin | Experimental | Paclitaxel 175mg/m2, Day 1,cisplatin 75mg/m2,Day 1,SHR-1210 200mg,Day 2,every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance |
|
| placebo+paclitaxel + cisplatin | Active Comparator | Paclitaxel 175mg/m2, Day 1,cisplatin 75mg/m2,Day 1,placebo,Day 2,every 3 weeks, maximum 6 cycles, then placebo maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 200mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by IRC | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| 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. | approximately 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigators | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| 6 and 9 month OS rate | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antidrug Antibodies (ADAs) | To evaluate the incidence of ADAs against SHR-1210 | approximately 22 months |
Inclusion Criteria:
Exclusion Criteria:
Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
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 | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Cancer Center of Sun-Yat Sen University (CCSYSU) | Principal Investigator |
| Qing Yang | Jiangsu HengRui Medicine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Sun-Yat Sen University (CCSYSU) | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37139963 | Derived | Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4. | |
| 34519801 |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Placebo | Drug | Placebo |
|
| paclitaxel | Drug | paclitaxel 175mg/m2 |
|
| cisplatin | Drug | cisplatin 75mg/m2 |
|
| approximately 6 and 9 months |
| ORR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| DCR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| DoR | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | approximately 22 months |
| AE | adverse events | approximately 22 months |
| Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |