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A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03764293
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic and Unresectable HCC Drug: SHR-1210 Drug: Apatinib Drug: Sorafenib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: SHR-1210
SHR-1210+Apatinib
Drug: SHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial

Drug: Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet

Active Comparator: Control
Sorafenib
Drug: Sorafenib
Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet




Primary Outcome Measures :
  1. To compare the overall survival (OS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
  2. To compare the progression-free survival (PFS) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. To compare the time to progression (TTP) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
  2. To compare objective response rate (ORR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
  3. To compare disease control rate (DCR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
  4. To compare duration of response (DoR) of SHR-1210 plus apatinib with sorafenib [ Time Frame: Up to approximately 3 years ]
  5. 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 ]
  6. Serum concentration of SHR-1210 and plasma concentration of apatinib [ Time Frame: Up to approximately 3 years ]
  7. 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:
  1. To evaluate the time to deteriation (TTD) of SHR-1210 plus apatinib versus sorafenib [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764293


Contacts
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Contact: Linna Wang, MD 086-021-60453196 wanglinna@hrglobe.com

Locations
Hide Hide 37 study locations
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China, Anhui
Anhui Provincal Cancer Hospital Recruiting
Hefei, Anhui, China, 230000
Contact: Yifu He         
Anhui Provincal Hospital Not yet recruiting
Hefei, Anhui, China, 230000
Contact: Weidong Jia         
The First Affiliated Hospital Of Anhui Medical University Not yet recruiting
Hefei, Anhui, China, 230009
Contact: Kangsheng Gu         
The Second Affiliated Hospital Of Anhui Medical University Recruiting
Hefei, Anhui, China, 230601
Contact: Zhendong Chen         
China, Beijing
Chinese Academy of Medical Sciences Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100020
Contact: Lin Yang         
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100089
Contact: Baocai Xing         
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100089
Contact: Chunyi Hao         
Peking University International Hospital Recruiting
Beijing, Beijing, China, 102206
Contact: Jun Liang         
China, Chongqing
The Second Hospital Affiliated To AMU Not yet recruiting
Chongqing, Chongqing, China, 400037
Contact: Ping Hao         
The First Hospital Affiliated To AMU Recruiting
Chongqing, Chongqing, China, 400038
Contact: Houjie Liang         
TheThird Affiliated Hospital ,Army Medical University Not yet recruiting
Chongqing, Chongqing, China, 400042
Contact: Dong Wang         
The Second Affiliated Hospital of ChongQing Medical University Recruiting
Chongqing, Chongqing, China, 400060
Contact: Hong Ren         
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Xiaoyan Lin         
China, Gansu
The 940th Hospital of the joint logistic support force of People's Liberation Army Recruiting
Lanzhou, Gansu, China
Contact: Baihong Zhang         
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Xu         
Sun Yat-sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510220
Contact: Yajin Chen         
NanFang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Yabing Guo         
China, Guangxi
The first affiliated hospital of guangxi medical university Recruiting
Nanning, Guangxi, China, 530021
Contact: Xiaohua Hu         
China, Hebei
The Fourth Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Da Jiang         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Yuxian Bai         
China, Hubei
Wuhan Union Hospital,Tongji Medical College,Huazhong University of Science&Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Tao Zhang         
Tongji hospital,Tongji Medical College,Huazhong University of Science&Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Xianglin Yan         
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 410006
Contact: Shanzhi Gu         
China, Jiangsu
The 81st Hospital of People's Liberation Army Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Shukui Qin, MD         
China, Jiangxi
The First Affiliated Hospital Of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Jianping Xiong         
China, Jilin
Jilin Cancer Hospital Not yet recruiting
Changchun, Jilin, China, 130000
Contact: Ying Cheng         
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Wei Li         
China, Liaoning
Shenyang 6th people's hospital Recruiting
Shengyang, Liaoning, China, 110006
Contact: Fang Yang         
Liaoning Cancer Hospital Recruiting
Shenyang, Liaoning, China, 110042
Contact: Jingdong Zhang         
China, Shandong
Shandong Cancer Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Shu Zhang         
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhiqiang Meng         
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhenggang Ren         
Shanghai Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200043
Contact: Xiaofeng zhai         
China, Sichuan
Sichuan Cancer Hospital&Institute Recruiting
Chengdu, Sichuan, China, 610054
Contact: Yongdong Jin         
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Da Li         
ZheJiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jieer Ying         
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Weijia Fang         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Shukui Qin, MD The 81st Hospital of People's Liberation Army

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03764293    
Other Study ID Numbers: SHR-1210-III-310
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sorafenib
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action