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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


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

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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

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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     History of Changes
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