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In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab | Experimental |
| |
| Investigator's Choice of Standard Therapy | Active Comparator | Docetaxel or Irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab | Biological | Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | approximately 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of PLA | Beijing | Beijing Municipality | China | |||
| Cancer Hospital Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32416073 | Derived | Huang J, Xu J, Chen Y, Zhuang W, Zhang Y, Chen Z, Chen J, Zhang H, Niu Z, Fan Q, Lin L, Gu K, Liu Y, Ba Y, Miao Z, Jiang X, Zeng M, Chen J, Fu Z, Gan L, Wang J, Zhan X, Liu T, Li Z, Shen L, Shu Y, Zhang T, Yang Q, Zou J; ESCORT Study Group. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2020 Jun;21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Camrelizumab | camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks |
| FG001 | Investigator's Choice of Standard Therapy | Docetaxel or Irinotecan Docetaxel: Subjects received Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks Irinotecan: Subjects received Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Camrelizumab | camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks |
| BG001 | Investigator's Choice of Standard Therapy | Docetaxel or Irinotecan Docetaxel: Subjects received Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks Irinotecan: Subjects received Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Posted | Median | 95% Confidence Interval | months | approximately 24 months |
|
approximately 24 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Camrelizumab | camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Sun; Project Manager | Jiangsu HengRui Pharmaceuticals Co., Ltd. | +86-18036618554 | shiwei.sun@hengrui.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2018 | Apr 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2017 | Apr 26, 2023 | SAP_001.pdf |
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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 |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks |
|
| Irinotecan | Drug | Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks |
|
| Beijing |
| Beijing Municipality |
| China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 23 |
| 228 |
| 71 |
| 228 |
| 226 |
| 228 |
| EG001 | Investigator's Choice of Standard Therapy | Docetaxel or Irinotecan Docetaxel: Subjects received Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks Irinotecan: Subjects received Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks | 10 | 220 | 52 | 220 | 210 | 220 |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Reactive Oral Capillary Endothelial Proliferation | Gastrointestinal disorders | Systematic Assessment |
|
| Esophageal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal Fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diaphragmatic Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Noninfective Gingivitis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oesophagobronchial Fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tracheal Mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lung Infection | Infections and infestations | Systematic Assessment |
|
| H1N1 Influenza | Infections and infestations | Systematic Assessment |
|
| Viral Infection | Infections and infestations | Systematic Assessment |
|
| Soft Tissue Infection | Infections and infestations | Systematic Assessment |
|
| Carbuncle | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Anal Infection | Infections and infestations | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Multiple Organ Dysfunction Syndrome | General disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | Systematic Assessment |
|
| Chronic Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Reactive Cutaneous Capillary Endothelial Proliferation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Blood Calcium Increased | Investigations | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bone Marrow Toxicity | Blood and lymphatic system disorders | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nasal Mucosa Reactive Capillary Endothelial Proliferation | Vascular disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Venous Thrombosis Limb | Vascular disorders | Systematic Assessment |
|
| Circulatory Collapse | Vascular disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Adrenal Insufficiency | Endocrine disorders | Systematic Assessment |
|
| Myasthenia Gravis | Nervous system disorders | Systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | Systematic Assessment |
|
| Device Loosening | Product Issues | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | Systematic Assessment |
|
| Anastomotic Ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophageal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Neutrophil count increased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood albumin decreased | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Reactive cutaneous capillary endothelial proliferation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |