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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.

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03764293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 25, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • 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 v5.0 [ 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: December 3, 2018)
To evaluate the time to deteriation (TTD) of SHR-1210 plus apatinib versus sorafenib [ Time Frame: Up to approximately 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced or Metastatic and Unresectable HCC
Intervention  ICMJE
  • 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
  • Drug: Sorafenib
    Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet
Study Arms  ICMJE
  • Experimental: SHR-1210
    SHR-1210+Apatinib
    Interventions:
    • Drug: SHR-1210
    • Drug: Apatinib
  • Active Comparator: Control
    Sorafenib
    Intervention: Drug: Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 25, 2018)
510
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
504
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linna Wang, MD 086-021-60453196 wanglinna@hrglobe.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03764293
Other Study ID Numbers  ICMJE SHR-1210-III-310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shukui Qin, MD The 81st Hospital of People's Liberation Army
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP