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

  • End date
    Jun 23, 2022
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 23 January 2021


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 Locally Advanced or Metastatic and Unresectable HCC
Treatment Sorafenib, apatinib, SHR-1210
Clinical Study IdentifierNCT03764293
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on23 January 2021


Yes No Not Sure

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
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