Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03099382

Recruitment Status : Completed

First Posted : April 4, 2017

Results First Posted : January 22, 2024

Last Update Posted : January 22, 2024

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Sponsor:

Information provided by (Responsible Party):

Jiangsu HengRui Medicine Co., Ltd.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Esophageal Carcinoma
Interventions	Biological: camrelizumab Drug: Docetaxel Drug: Irinotecan
Enrollment	457

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Camrelizumab	Investigator's Choice of Standard Therapy
Arm/Group Description	camrelizumab: Subjects received cam...	Docetaxel or Irinotecan ...
Arm/Group Description	camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks	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
Period Title: Overall Study
Started	228	220
Completed	226	217
Not Completed	2	3
Reason Not Completed
Protocol Violation	2	3

Baseline Characteristics

Arm/Group Title		Camrelizumab	Investigator's Choice of Standard Therapy	Total
Arm/Group Description		camrelizumab: Subjects received cam...	Docetaxel or Irinotecan ...	Total of all reporting groups
Arm/Group Description		camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks	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	Total of all reporting groups
Overall Number of Baseline Participants		228	220	448
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	228 participants	220 participants	448 participants
		59.3 (7.46)	59.5 (6.68)	59.4 (7.08)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	228 participants	220 participants	448 participants
	Female	20 8.8%	28 12.7%	48 10.7%
	Male	208 91.2%	192 87.3%	400 89.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	228 participants	220 participants	448 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	228 100.0%	220 100.0%	448 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
China	Number Analyzed	228 participants	220 participants	448 participants
China		228	220	448

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	approximately 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Camrelizumab	Investigator's Choice of Standard Therapy
Arm/Group Description:	camrelizumab: Subjects received cam...	Docetaxel or Irinotecan ...
Arm/Group Description:	camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks	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
Overall Number of Participants Analyzed	228	220
Median (95% Confidence Interval) Unit of Measure: months
	8.28 (6.77 to 9.72)	6.24 (5.68 to 6.93)

Adverse Events

Time Frame	approximately 24 months
Adverse Event Reporting Description	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.

Arm/Group Title	Camrelizumab	Investigator's Choice of Standard Therapy
Arm/Group Description	camrelizumab: Subjects received cam...	Docetaxel or Irinotecan ...
Arm/Group Description	camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks	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
All-Cause Mortality
	Camrelizumab	Investigator's Choice of Standard Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	23/228 (10.09%)	10/220 (4.55%)
Serious Adverse Events Serious Adverse Events
	Camrelizumab	Investigator's Choice of Standard Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	71/228 (31.14%)	52/220 (23.64%)
Blood and lymphatic system disorders
Anemia ^†	2/228 (0.88%)	3/220 (1.36%)
Febrile Neutropenia ^†	0/228 (0.00%)	2/220 (0.91%)
Bone Marrow Toxicity ^†	0/228 (0.00%)	2/220 (0.91%)
Granulocytopenia ^†	0/228 (0.00%)	2/220 (0.91%)
Cardiac disorders
Myocarditis ^†	2/228 (0.88%)	0/220 (0.00%)
Myocardial Infarction ^†	1/228 (0.44%)	1/220 (0.45%)
Acute Myocardial Infarction ^†	1/228 (0.44%)	0/220 (0.00%)
Cardiac Failure ^†	1/228 (0.44%)	0/220 (0.00%)
Endocrine disorders
Hypothyroidism ^†	1/228 (0.44%)	0/220 (0.00%)
Adrenal Insufficiency ^†	1/228 (0.44%)	0/220 (0.00%)
Gastrointestinal disorders
Dysphagia ^†	4/228 (1.75%)	1/220 (0.45%)
Gastrointestinal Haemorrhage ^†	3/228 (1.32%)	1/220 (0.45%)
Upper Gastrointestinal Haemorrhage ^†	2/228 (0.88%)	3/220 (1.36%)
Reactive Oral Capillary Endothelial Proliferation ^†	2/228 (0.88%)	0/220 (0.00%)
Esophageal Obstruction ^†	2/228 (0.88%)	0/220 (0.00%)
Oesophageal Fistula ^†	2/228 (0.88%)	0/220 (0.00%)
Diarrhea ^†	1/228 (0.44%)	3/220 (1.36%)
Subileus ^†	1/228 (0.44%)	0/220 (0.00%)
Haematemesis ^†	1/228 (0.44%)	0/220 (0.00%)
Oesophageal Haemorrhage ^†	1/228 (0.44%)	0/220 (0.00%)
Gastrointestinal Pain ^†	1/228 (0.44%)	0/220 (0.00%)
Gastric Obstruction ^†	1/228 (0.44%)	0/220 (0.00%)
Enterocolitis ^†	1/228 (0.44%)	0/220 (0.00%)
Pancreatitis ^†	1/228 (0.44%)	0/220 (0.00%)
Diaphragmatic Hernia ^†	1/228 (0.44%)	0/220 (0.00%)
Vomiting ^†	0/228 (0.00%)	5/220 (2.27%)
Nausea ^†	0/228 (0.00%)	2/220 (0.91%)
Ileus ^†	0/228 (0.00%)	1/220 (0.45%)
Noninfective Gingivitis ^†	0/228 (0.00%)	1/220 (0.45%)
Gastrointestinal Perforation ^†	0/228 (0.00%)	1/220 (0.45%)
General disorders
Death ^†	5/228 (2.19%)	3/220 (1.36%)
Pyrexia ^†	3/228 (1.32%)	0/220 (0.00%)
Asthenia ^†	2/228 (0.88%)	0/220 (0.00%)
Multiple Organ Dysfunction Syndrome ^†	0/228 (0.00%)	1/220 (0.45%)
Hepatobiliary disorders
Hepatic Function Abnormal ^†	4/228 (1.75%)	1/220 (0.45%)
Chronic Cholecystitis ^†	0/228 (0.00%)	1/220 (0.45%)
Immune system disorders
Drug Hypersensitivity ^†	0/228 (0.00%)	1/220 (0.45%)
Infections and infestations
Lung Infection ^†	7/228 (3.07%)	7/220 (3.18%)
H1N1 Influenza ^†	1/228 (0.44%)	0/220 (0.00%)
Viral Infection ^†	1/228 (0.44%)	0/220 (0.00%)
Soft Tissue Infection ^†	1/228 (0.44%)	0/220 (0.00%)
Carbuncle ^†	1/228 (0.44%)	0/220 (0.00%)
Bronchitis ^†	1/228 (0.44%)	0/220 (0.00%)
Upper Respiratory Tract Infection ^†	0/228 (0.00%)	2/220 (0.91%)
Anal Infection ^†	0/228 (0.00%)	1/220 (0.45%)
Injury, poisoning and procedural complications
Anastomotic Ulcer ^†	0/228 (0.00%)	1/220 (0.45%)
Investigations
Alanine Aminotransferase Increased ^†	1/228 (0.44%)	0/220 (0.00%)
Aspartate Aminotransferase Increased ^†	1/228 (0.44%)	0/220 (0.00%)
Blood Bilirubin Increased ^†	1/228 (0.44%)	0/220 (0.00%)
Blood Calcium Increased ^†	1/228 (0.44%)	0/220 (0.00%)
White Blood Cell Count Decreased ^†	0/228 (0.00%)	6/220 (2.73%)
Neutrophil Count Decreased ^†	0/228 (0.00%)	3/220 (1.36%)
Platelet Count Decreased ^†	0/228 (0.00%)	1/220 (0.45%)
Metabolism and nutrition disorders
Decreased Appetite ^†	1/228 (0.44%)	6/220 (2.73%)
Hyponatraemia ^†	1/228 (0.44%)	0/220 (0.00%)
Hypercalcaemia ^†	1/228 (0.44%)	0/220 (0.00%)
Diabetic Ketoacidosis ^†	1/228 (0.44%)	0/220 (0.00%)
Malnutrition ^†	1/228 (0.44%)	0/220 (0.00%)
Hypoalbuminaemia ^†	0/228 (0.00%)	1/220 (0.45%)
Musculoskeletal and connective tissue disorders
Back Pain ^†	1/228 (0.44%)	0/220 (0.00%)
Myositis ^†	1/228 (0.44%)	0/220 (0.00%)
Neck Pain ^†	1/228 (0.44%)	0/220 (0.00%)
Pain in Extremity ^†	1/228 (0.44%)	0/220 (0.00%)
Nervous system disorders
Myasthenia Gravis ^†	1/228 (0.44%)	0/220 (0.00%)
Loss of Consciousness ^†	0/228 (0.00%)	1/220 (0.45%)
Product Issues
Device Loosening ^†	1/228 (0.44%)	0/220 (0.00%)
Psychiatric disorders
Completed Suicide ^†	1/228 (0.44%)	0/220 (0.00%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia ^†	0/228 (0.00%)	1/220 (0.45%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis ^†	9/228 (3.95%)	3/220 (1.36%)
Oesophagobronchial Fistula ^†	2/228 (0.88%)	2/220 (0.91%)
Haemoptysis ^†	2/228 (0.88%)	1/220 (0.45%)
Tracheal Stenosis ^†	2/228 (0.88%)	0/220 (0.00%)
Pleural Effusion ^†	2/228 (0.88%)	0/220 (0.00%)
Dyspnoea ^†	1/228 (0.44%)	1/220 (0.45%)
Respiratory Failure ^†	1/228 (0.44%)	1/220 (0.45%)
Pneumonia Aspiration ^†	1/228 (0.44%)	1/220 (0.45%)
Interstitial Lung Disease ^†	1/228 (0.44%)	0/220 (0.00%)
Tracheal Mass ^†	1/228 (0.44%)	0/220 (0.00%)
Pulmonary Embolism ^†	0/228 (0.00%)	1/220 (0.45%)
Skin and subcutaneous tissue disorders
Reactive Cutaneous Capillary Endothelial Proliferation ^†	4/228 (1.75%)	0/220 (0.00%)
Vascular disorders
Nasal Mucosa Reactive Capillary Endothelial Proliferation ^†	1/228 (0.44%)	0/220 (0.00%)
Deep Vein Thrombosis ^†	1/228 (0.44%)	0/220 (0.00%)
Venous Thrombosis Limb ^†	0/228 (0.00%)	1/220 (0.45%)
Circulatory Collapse ^†	0/228 (0.00%)	1/220 (0.45%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Camrelizumab	Investigator's Choice of Standard Therapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	226/228 (99.12%)	210/220 (95.45%)
Blood and lymphatic system disorders
Anaemia ^†	102/228 (44.74%)	107/220 (48.64%)
Cardiac disorders
Sinus tachycardia ^†	13/228 (5.70%)	6/220 (2.73%)
Endocrine disorders
Hypothyroidism ^†	40/228 (17.54%)	11/220 (5.00%)
Hyperthyroidism ^†	14/228 (6.14%)	2/220 (0.91%)
Gastrointestinal disorders
Constipation ^†	39/228 (17.11%)	26/220 (11.82%)
Diarrhoea ^†	31/228 (13.60%)	78/220 (35.45%)
Nausea ^†	19/228 (8.33%)	87/220 (39.55%)
Vomiting ^†	19/228 (8.33%)	64/220 (29.09%)
Abdominal distension ^†	13/228 (5.70%)	9/220 (4.09%)
Abdominal pain upper ^†	13/228 (5.70%)	6/220 (2.73%)
Oesophageal obstruction ^†	12/228 (5.26%)	2/220 (0.91%)
Dysphagia ^†	11/228 (4.82%)	12/220 (5.45%)
Abdominal pain ^†	4/228 (1.75%)	17/220 (7.73%)
General disorders
Asthenia ^†	54/228 (23.68%)	75/220 (34.09%)
Pyrexia ^†	38/228 (16.67%)	21/220 (9.55%)
Chest pain ^†	23/228 (10.09%)	19/220 (8.64%)
Oedema peripheral ^†	12/228 (5.26%)	2/220 (0.91%)
Chest discomfort ^†	9/228 (3.95%)	13/220 (5.91%)
Hepatobiliary disorders
Hepatic function abnormal ^†	14/228 (6.14%)	5/220 (2.27%)
Infections and infestations
Upper respiratory tract infection ^†	15/228 (6.58%)	11/220 (5.00%)
Investigations
Weight decreased ^†	44/228 (19.30%)	41/220 (18.64%)
Aspartate aminotransferase increased ^†	33/228 (14.47%)	17/220 (7.73%)
White blood cell count decreased ^†	33/228 (14.47%)	112/220 (50.91%)
Alanine aminotransferase increased ^†	24/228 (10.53%)	18/220 (8.18%)
Bilirubin conjugated increased ^†	19/228 (8.33%)	9/220 (4.09%)
Neutrophil count decreased ^†	17/228 (7.46%)	75/220 (34.09%)
White blood cell count increased ^†	16/228 (7.02%)	4/220 (1.82%)
Neutrophil count increased ^†	15/228 (6.58%)	5/220 (2.27%)
Lymphocyte count decreased ^†	14/228 (6.14%)	10/220 (4.55%)
Platelet count decreased ^†	14/228 (6.14%)	13/220 (5.91%)
Blood bilirubin increased ^†	12/228 (5.26%)	9/220 (4.09%)
Blood albumin decreased ^†	11/228 (4.82%)	15/220 (6.82%)
Haemoglobin decreased ^†	7/228 (3.07%)	16/220 (7.27%)
Metabolism and nutrition disorders
Hyponatraemia ^†	49/228 (21.49%)	20/220 (9.09%)
Decreased appetite ^†	44/228 (19.30%)	80/220 (36.36%)
Hypoalbuminaemia ^†	43/228 (18.86%)	26/220 (11.82%)
Hypoproteinaemia ^†	28/228 (12.28%)	17/220 (7.73%)
Hypokalaemia ^†	21/228 (9.21%)	17/220 (7.73%)
Musculoskeletal and connective tissue disorders
Back pain ^†	20/228 (8.77%)	18/220 (8.18%)
Musculoskeletal pain ^†	10/228 (4.39%)	14/220 (6.36%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^†	20/228 (8.77%)	9/220 (4.09%)
Psychiatric disorders
Insomnia ^†	16/228 (7.02%)	7/220 (3.18%)
Renal and urinary disorders
Proteinuria ^†	31/228 (13.60%)	13/220 (5.91%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	52/228 (22.81%)	31/220 (14.09%)
Dyspnoea ^†	17/228 (7.46%)	16/220 (7.27%)
Productive cough ^†	17/228 (7.46%)	13/220 (5.91%)
Haemoptysis ^†	15/228 (6.58%)	2/220 (0.91%)
Pleural effusion ^†	12/228 (5.26%)	1/220 (0.45%)
Pneumonitis ^†	12/228 (5.26%)	2/220 (0.91%)
Skin and subcutaneous tissue disorders
Reactive cutaneous capillary endothelial proliferation ^†	181/228 (79.39%)	0/220 (0.00%)
Pruritus ^†	12/228 (5.26%)	6/220 (2.73%)
Alopecia ^†	0/228 (0.00%)	21/220 (9.55%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Shiwei Sun; Project Manager
Organization:	Jiangsu HengRui Pharmaceuticals Co., Ltd.
Phone:	+86-18036618554
EMail:	shiwei.sun@hengrui.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:	NCT03099382
Other Study ID Numbers:	SHR-1210-III-301-ESC
First Submitted:	March 28, 2017
First Posted:	April 4, 2017
Results First Submitted:	April 26, 2023
Results First Posted:	January 22, 2024
Last Update Posted:	January 22, 2024

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