A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

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ClinicalTrials.gov Identifier: NCT02989922

Recruitment Status : Completed

First Posted : December 12, 2016

Results First Posted : March 15, 2024

Last Update Posted : March 15, 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	Hepatocellular Carcinoma Non-Resectable
Intervention	Biological: SHR-1210
Enrollment	220

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Period Title: Overall Study
Started	111	109
Treated	109	108
Completed	72	81
Not Completed	39	28

Baseline Characteristics

Arm/Group Title		SHR-1210 Q2W	SHR-1210 Q3W	Total
Arm/Group Description		Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...	Total of all reporting groups
Arm/Group Description		Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Total of all reporting groups
Overall Number of Baseline Participants		109	108	217
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	109 participants	108 participants	217 participants
		48.0 (25 to 80)	49.5 (23 to 76)	49.0 (23 to 80)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	109 participants	108 participants	217 participants
	Female	11 10.1%	10 9.3%	21 9.7%
	Male	98 89.9%	98 90.7%	196 90.3%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
China	Number Analyzed	109 participants	108 participants	217 participants
China		109	108	217

Outcome Measures

1.Primary Outcome


Title	Objective Response Rate
Description	Tumour responses were evaluated by the independent review committee (I...
Description	Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).
Time Frame	approximate 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description:	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description:	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Number of Participants Analyzed	109	108
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	11.9 (6.5 to 19.5)	16.7 (10.2 to 25.1)

2.Primary Outcome


Title	6-month Overall Survival Rate
Description	6-month overall survival rate (defined as cumulative overall survival ...
Description	6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)
Time Frame	from the date of the first dose to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description:	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description:	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Number of Participants Analyzed	109	108
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	75.9 (66.6 to 82.9)	73.0 (63.6 to 80.4)

3.Secondary Outcome


Title	Duration of Response
Description	time from first response to progression or death base on the IRC asses...
Description	time from first response to progression or death base on the IRC assessment
Time Frame	approximate 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description:	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description:	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Number of Participants Analyzed	109	108
Median (95% Confidence Interval) Unit of Measure: months
	30.4 ^[1] (2.8 to NA)	30.5 ^[1] (5.4 to NA)

[1]

not reached (due to insufficient number of subjects with events).

4.Secondary Outcome


Title	Adverse Events
Description	Number of Subjects with one or more adverse events as assessed by CTCA...
Description	Number of Subjects with one or more adverse events as assessed by CTCAE 4.03
Time Frame	approximate 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description:	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description:	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Number of Participants Analyzed	109	108
Measure Type: Number Unit of Measure: participants
	109	108

5.Secondary Outcome


Title	Overall Survival
Description	Time from first dose to death from any cause
Description	Time from first dose to death from any cause
Time Frame	approximate 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description:	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description:	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Overall Number of Participants Analyzed	109	108
Median (95% Confidence Interval) Unit of Measure: months
	14.3 (11.5 to 19.5)	13.2 (9.4 to 16.3)

Adverse Events

Time Frame	approximate 3 years
Adverse Event Reporting Description	Adverse events were monitored and recorded from the time of informed consent until 90 days after last administration and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Arm/Group Title	SHR-1210 Q2W	SHR-1210 Q3W
Arm/Group Description	Subjects receive SHR-1210 intraveno...	Subjects receive SHR-1210 intraveno...
Arm/Group Description	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks SHR-1210: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
All-Cause Mortality
	SHR-1210 Q2W	SHR-1210 Q3W
	Affected / at Risk (%)	Affected / at Risk (%)
Total	27/109 (24.77%)	29/108 (26.85%)
Serious Adverse Events Serious Adverse Events
	SHR-1210 Q2W	SHR-1210 Q3W
	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/109 (45.87%)	46/108 (42.59%)
Blood and lymphatic system disorders
Hypersplenism ^†	1/109 (0.92%)	0/108 (0.00%)
Cardiac disorders
Acute coronary syndrome ^†	0/109 (0.00%)	1/108 (0.93%)
Supraventricular tachycardia ^†	1/109 (0.92%)	0/108 (0.00%)
Ear and labyrinth disorders
Vertigo ^†	0/109 (0.00%)	1/108 (0.93%)
Endocrine disorders
Thyroiditis ^†	1/109 (0.92%)	0/108 (0.00%)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage ^†	2/109 (1.83%)	4/108 (3.70%)
Ascites ^†	1/109 (0.92%)	1/108 (0.93%)
Oral reactive capillary endothelial proliferation ^†	2/109 (1.83%)	0/108 (0.00%)
Gastric haemorrhage ^†	1/109 (0.92%)	0/108 (0.00%)
Gastrointestinal haemorrhage ^†	0/109 (0.00%)	1/108 (0.93%)
Subileus ^†	1/109 (0.92%)	0/108 (0.00%)
General disorders
Disease progression ^†	13/109 (11.93%)	9/108 (8.33%)
Multiple organ dysfunction syndrome ^†	3/109 (2.75%)	3/108 (2.78%)
Death ^†	0/109 (0.00%)	2/108 (1.85%)
Pain ^†	1/109 (0.92%)	0/108 (0.00%)
Hepatobiliary disorders
Hepatic function abnormal ^†	2/109 (1.83%)	6/108 (5.56%)
Hepatic failure ^†	4/109 (3.67%)	3/108 (2.78%)
Jaundice cholestatic ^†	2/109 (1.83%)	1/108 (0.93%)
Autoimmune hepatitis ^†	1/109 (0.92%)	0/108 (0.00%)
Cholecystitis ^†	0/109 (0.00%)	1/108 (0.93%)
Liver injury ^†	1/109 (0.92%)	0/108 (0.00%)
Infections and infestations
Lung infection ^†	2/109 (1.83%)	1/108 (0.93%)
Upper respiratory tract infection ^†	2/109 (1.83%)	0/108 (0.00%)
Abdominal infection ^†	0/109 (0.00%)	1/108 (0.93%)
Pneumonia ^†	1/109 (0.92%)	0/108 (0.00%)
Splenic abscess ^†	1/109 (0.92%)	0/108 (0.00%)
Injury, poisoning and procedural complications
Craniocerebral injury ^†	0/109 (0.00%)	1/108 (0.93%)
Foot fracture ^†	0/109 (0.00%)	1/108 (0.93%)
Hepatic rupture ^†	0/109 (0.00%)	1/108 (0.93%)
Investigations
Aspartate aminotransferase increased ^†	3/109 (2.75%)	0/108 (0.00%)
Alanine aminotransferase increased ^†	1/109 (0.92%)	1/108 (0.93%)
Blood bilirubin increased ^†	2/109 (1.83%)	0/108 (0.00%)
Platelet count decreased ^†	2/109 (1.83%)	0/108 (0.00%)
Blood glucose increased ^†	0/109 (0.00%)	1/108 (0.93%)
Gamma-glutamyltransferase increased ^†	0/109 (0.00%)	1/108 (0.93%)
Neutrophil count decreased ^†	1/109 (0.92%)	0/108 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^†	1/109 (0.92%)	0/108 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression ^†	3/109 (2.75%)	2/108 (1.85%)
Hepatic cancer ^†	0/109 (0.00%)	4/108 (3.70%)
Intracranial tumour haemorrhage ^†	2/109 (1.83%)	2/108 (1.85%)
Oncologic complication ^†	0/109 (0.00%)	1/108 (0.93%)
Tumour rupture ^†	0/109 (0.00%)	1/108 (0.93%)
Uterine leiomyoma ^†	0/109 (0.00%)	1/108 (0.93%)
Nervous system disorders
Cerebrovascular accident ^†	0/109 (0.00%)	1/108 (0.93%)
Coma ^†	1/109 (0.92%)	0/108 (0.00%)
Hepatic encephalopathy ^†	0/109 (0.00%)	1/108 (0.93%)
Renal and urinary disorders
Proteinuria ^†	1/109 (0.92%)	0/108 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis ^†	1/109 (0.92%)	2/108 (1.85%)
Pleural effusion ^†	1/109 (0.92%)	1/108 (0.93%)
Dyspnoea ^†	0/109 (0.00%)	1/108 (0.93%)
Haemothorax ^†	1/109 (0.92%)	0/108 (0.00%)
Interstitial lung disease ^†	1/109 (0.92%)	0/108 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis ^†	1/109 (0.92%)	0/108 (0.00%)
Drug eruption ^†	0/109 (0.00%)	1/108 (0.93%)
Reactive cutaneous capillary endothelial proliferation ^†	0/109 (0.00%)	1/108 (0.93%)
Vascular disorders
Angiopathy ^†	1/109 (0.92%)	0/108 (0.00%)
Nasal mucosal reactive capillary endothelial proliferation ^†	0/109 (0.00%)	1/108 (0.93%)
Vascular rupture ^†	1/109 (0.92%)	0/108 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SHR-1210 Q2W	SHR-1210 Q3W
	Affected / at Risk (%)	Affected / at Risk (%)
Total	108/109 (99.08%)	107/108 (99.07%)
Blood and lymphatic system disorders
Anaemia ^†	27/109 (24.77%)	28/108 (25.93%)
Endocrine disorders
Hypothyroidism ^†	14/109 (12.84%)	13/108 (12.04%)
Hyperthyroidism ^†	6/109 (5.50%)	6/108 (5.56%)
Gastrointestinal disorders
Diarrhoea ^†	17/109 (15.60%)	20/108 (18.52%)
Abdominal distension ^†	11/109 (10.09%)	15/108 (13.89%)
Ascites ^†	12/109 (11.01%)	13/108 (12.04%)
Abdominal pain ^†	11/109 (10.09%)	10/108 (9.26%)
Abdominal pain upper ^†	7/109 (6.42%)	13/108 (12.04%)
Nausea ^†	10/109 (9.17%)	8/108 (7.41%)
Constipation ^†	5/109 (4.59%)	6/108 (5.56%)
General disorders
Pyrexia ^†	26/109 (23.85%)	23/108 (21.30%)
Asthenia ^†	23/109 (21.10%)	23/108 (21.30%)
Oedema peripheral ^†	7/109 (6.42%)	6/108 (5.56%)
Chest pain ^†	7/109 (6.42%)	4/108 (3.70%)
Hepatobiliary disorders
Hepatic function abnormal ^†	10/109 (9.17%)	15/108 (13.89%)
Jaundice ^†	3/109 (2.75%)	9/108 (8.33%)
Infections and infestations
Upper respiratory tract infection ^†	17/109 (15.60%)	12/108 (11.11%)
Urinary tract infection ^†	3/109 (2.75%)	8/108 (7.41%)
Investigations
Aspartate aminotransferase increased ^†	52/109 (47.71%)	48/108 (44.44%)
Alanine aminotransferase increased ^†	47/109 (43.12%)	46/108 (42.59%)
Blood bilirubin increased ^†	40/109 (36.70%)	38/108 (35.19%)
Platelet count decreased ^†	35/109 (32.11%)	39/108 (36.11%)
White blood cell count decreased ^†	24/109 (22.02%)	31/108 (28.70%)
Neutrophil count decreased ^†	23/109 (21.10%)	26/108 (24.07%)
Weight increased ^†	27/109 (24.77%)	21/108 (19.44%)
Bilirubin conjugated increased ^†	25/109 (22.94%)	20/108 (18.52%)
Gamma-glutamyltransferase increased ^†	17/109 (15.60%)	28/108 (25.93%)
Blood alkaline phosphatase increased ^†	18/109 (16.51%)	21/108 (19.44%)
Weight decreased ^†	14/109 (12.84%)	17/108 (15.74%)
Blood albumin decreased ^†	13/109 (11.93%)	11/108 (10.19%)
Blood lactate dehydrogenase increased ^†	9/109 (8.26%)	15/108 (13.89%)
Lymphocyte count decreased ^†	10/109 (9.17%)	13/108 (12.04%)
Blood thyroid stimulating hormone increased ^†	11/109 (10.09%)	10/108 (9.26%)
Lipase increased ^†	7/109 (6.42%)	12/108 (11.11%)
Blood bilirubin unconjugated increased ^†	8/109 (7.34%)	10/108 (9.26%)
Hepatitis B DNA increased ^†	7/109 (6.42%)	11/108 (10.19%)
Protein urine present ^†	5/109 (4.59%)	8/108 (7.41%)
Neutrophil count increased ^†	2/109 (1.83%)	8/108 (7.41%)
White blood cell count increased ^†	1/109 (0.92%)	9/108 (8.33%)
Blood glucose increased ^†	6/109 (5.50%)	3/108 (2.78%)
Metabolism and nutrition disorders
Decreased appetite ^†	22/109 (20.18%)	19/108 (17.59%)
Hypokalaemia ^†	20/109 (18.35%)	18/108 (16.67%)
Hypoproteinaemia ^†	14/109 (12.84%)	16/108 (14.81%)
Hypoalbuminaemia ^†	16/109 (14.68%)	11/108 (10.19%)
Hyponatraemia ^†	13/109 (11.93%)	9/108 (8.33%)
Hyperglycaemia ^†	9/109 (8.26%)	6/108 (5.56%)
Hypomagnesaemia ^†	3/109 (2.75%)	6/108 (5.56%)
Musculoskeletal and connective tissue disorders
Back pain ^†	12/109 (11.01%)	7/108 (6.48%)
Arthralgia ^†	7/109 (6.42%)	3/108 (2.78%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin ^†	69/109 (63.30%)	76/108 (70.37%)
Nervous system disorders
Headache ^†	9/109 (8.26%)	4/108 (3.70%)
Psychiatric disorders
Insomnia ^†	3/109 (2.75%)	6/108 (5.56%)
Renal and urinary disorders
Proteinuria ^†	36/109 (33.03%)	29/108 (26.85%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	14/109 (12.84%)	17/108 (15.74%)
Haemoptysis ^†	6/109 (5.50%)	2/108 (1.85%)
Pneumonitis ^†	1/109 (0.92%)	7/108 (6.48%)
Skin and subcutaneous tissue disorders
Rash ^†	13/109 (11.93%)	12/108 (11.11%)
Vascular disorders
Hypertension ^†	18/109 (16.51%)	17/108 (15.74%)
† 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:	Linna Wang
Organization:	Jiangsu HengRui Pharmaceuticals Co., Ltd
Phone:	+862161053363
EMail:	linna.wang@hengrui.com

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

Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.

Qin S, Ren Z, Meng Z, Chen Z, Chai X, Xiong J, Bai Y, Yang L, Zhu H, Fang W, Lin X, Chen X, Li E, Wang L, Chen C, Zou J. Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial. Lancet Oncol. 2020 Apr;21(4):571-580. doi: 10.1016/S1470-2045(20)30011-5. Epub 2020 Feb 26.

Layout table for additonal information

Responsible Party:	Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02989922
Other Study ID Numbers:	SHR-1210-II/III-HCC
First Submitted:	November 22, 2016
First Posted:	December 12, 2016
Results First Submitted:	July 3, 2020
Results First Posted:	March 15, 2024
Last Update Posted:	March 15, 2024

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