Clinical Trials List
Protocol NumberSHR-1210-III-310
NCT Number(ClinicalTrials.gov Identfier)NCT03764293
2019-11-01 - 2025-02-28
Phase III
Recruiting8
ICD-10C22.9
Malignant neoplasm of liver, not specified as primary or secondary
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib (Rivoceranib) Mesylate Versus Sorafenib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ming-Huang Chen Division of Hematology & Oncology
- Yi-Ping Hung Digestive System Department
- San-Chi Chen Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
- Yun-Cheng Hsieh Digestive System Department
- Chung-Pin Li Division of General Internal Medicine
- Pei-Chang Lee Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Mo Hou Division of General Internal Medicine
- 呂嘉偉 Division of Radiology
- Cheng-Lung Hsu Division of General Internal Medicine
- Wen-Chi Chou Division of General Internal Medicine
- Chia-Hsun Hsieh Division of General Internal Medicine
- Jen-Shi Chen Division of General Internal Medicine
- Mengting Peng Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 簡世杰 Digestive System Department
- Chiu Hung Chiu Digestive System Department
- 劉奕廷 Division of General Internal Medicine
- Yih-Jyh Lin 未分科
- Shang-Yin Wu Division of General Internal Medicine
- Hsin-Yu Kuo Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張德生 Division of General Internal Medicine
- 顏志維 Division of General Internal Medicine
- 陳奕行 Division of General Internal Medicine
- 官鋒澤 Division of Hematology & Oncology
- 沈建亨 Division of General Internal Medicine
- 陳慰明 Division of General Internal Medicine
- 盧勝男 Division of General Internal Medicine
- 許晃維 Division of General Internal Medicine
- 許勝榮 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳彥仰 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- 賴香蘭 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Meng-Jer Hsieh Division of Hematology & Oncology
- 曾政豪 Digestive System Department
- 蔡英楠 Digestive System Department
- 曾兆明 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林宗哲 Division of Hematology & Oncology
- JA-DER LIANG Division of General Internal Medicine
- Ann-Lii Cheng Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
- 廖思涵 Division of General Internal Medicine
- Ying-Chun Shen Division of Hematology & Oncology
- Chien-Hung Chen Division of General Internal Medicine
- Ming-Chih Ho Division of General Surgery
- Chih-Hung Hsu Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- 曾岱宗 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Hepatocellular Carcinoma (HCC)
Objectives
Primary Study Objective• To compare the overall survival(OS) and progression-freesurvival (PFS) of SHR-1210combined with rivoceranibmesylate (experimental arm)with sorafenib (control arm) asfirst-line therapy for subjectswith advanced HCC who havenot previously receivedsystemic therapy. Secondary Study Objectives• To compare the efficacy ofSHR-1210 combined withrivoceranib mesylate versussorafenib as first-line therapy insubjects with advanced HCC,who have not previouslyreceived systemic therapy,through evaluations of PFS,time to progression (TTP),objective response rate (ORR),disease control rate (DCR), andduration of response (DoR); • To evaluate the safety of SHR1210 combined with rivoceranibmesylate versus sorafenib as afirst-line therapy for advancedHCC; To evaluate PK of SHR-1210and rivoceranib andimmunogenicity of SHR-1210,and to analyze theimmunogenicity of SHR-1210in combination with theconcentration of SHR-1210.
Test Drug
Camrelizumab (SHR-1210)、Rivoceranib (Apatinib) mesylate
Active Ingredient
Camrelizumab
Rivoceranib mesylate
Rivoceranib mesylate
Dosage Form
IVT
tablet
tablet
Dosage
200 mg
0.25 g
0.25 g
Endpoints
Primary Outcome Measures :
To compare the overall survival (OS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare the progression-free survival (PFS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
Secondary Outcome Measures :
To compare the time to progression (TTP) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare objective response rate (ORR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare disease control rate (DCR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare duration of response (DoR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of SHR-1210 plus apatinib versus sorafenib as assessed by CTCAE v4.03 [ Time Frame: Up to approximately 3 years ]
Serum concentration of SHR-1210 and plasma concentration of apatinib [ Time Frame: Up to approximately 3 years ]
Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [ Time Frame: Up to approximately 3 years ]
Other Outcome Measures:
To evaluate the time to deteriation (TTD) of SHR-1210 plus apatinib versus sorafenib [ Time Frame: Up to approximately 3 years ]
To compare the overall survival (OS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare the progression-free survival (PFS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
Secondary Outcome Measures :
To compare the time to progression (TTP) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare objective response rate (ORR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare disease control rate (DCR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
To compare duration of response (DoR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of SHR-1210 plus apatinib versus sorafenib as assessed by CTCAE v4.03 [ Time Frame: Up to approximately 3 years ]
Serum concentration of SHR-1210 and plasma concentration of apatinib [ Time Frame: Up to approximately 3 years ]
Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [ Time Frame: Up to approximately 3 years ]
Other Outcome Measures:
To evaluate the time to deteriation (TTD) of SHR-1210 plus apatinib versus sorafenib [ Time Frame: Up to approximately 3 years ]
Inclution Criteria
Inclusion Criteria:
Histopathologically or cytologically confirmed advanced HCC
No previous systematic treatment for HCC
Have at least one measurable lesion (in accordance with RECIST v1.1)
BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
ECOG-PS score 0 or 1
Child-Pugh Class: Grade A
Life Expectancy of at least 12 weeks
Subjects with HBV infection: HBV DNA<500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
Subjects with HCV-RNA(+) must receive antiviral therapy
Adequate organ function
Histopathologically or cytologically confirmed advanced HCC
No previous systematic treatment for HCC
Have at least one measurable lesion (in accordance with RECIST v1.1)
BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
ECOG-PS score 0 or 1
Child-Pugh Class: Grade A
Life Expectancy of at least 12 weeks
Subjects with HBV infection: HBV DNA<500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
Subjects with HCV-RNA(+) must receive antiviral therapy
Adequate organ function
Exclusion Criteria
Exclusion Criteria:
Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
Moderate-to-severe ascites with clinical symptoms
History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
Known genetic or acquired hemorrhage or thrombotic tendency
Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
Cardiac clinical symptom or disease that is not well controlled
Hypertension that can not be well controlled through antihypertensive drugs
Factors to affect oral administration
History of hepatic encephalopathy
Previous or current presence of metastasis to central nervous system
HIV infection
Combined hepatitis B and hepatitis C co-infection
Be ready for or previously received organ or allogenic bone marrow transplantation
Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
Active known, or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
Severe infection within 4 weeks prior to the start of study treatment
Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
Treatment of other investigational product(s) within 28 days prior to the start of study treatment
Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
Moderate-to-severe ascites with clinical symptoms
History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
Known genetic or acquired hemorrhage or thrombotic tendency
Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
Cardiac clinical symptom or disease that is not well controlled
Hypertension that can not be well controlled through antihypertensive drugs
Factors to affect oral administration
History of hepatic encephalopathy
Previous or current presence of metastasis to central nervous system
HIV infection
Combined hepatitis B and hepatitis C co-infection
Be ready for or previously received organ or allogenic bone marrow transplantation
Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
Active known, or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
Severe infection within 4 weeks prior to the start of study treatment
Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
Treatment of other investigational product(s) within 28 days prior to the start of study treatment
The Estimated Number of Participants
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Taiwan
40 participants
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Global
510 participants
