For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Histopathologically or cytologically confirmed advanced HCC
  2. No previous systematic treatment for HCC
  3. Have at least one measurable lesion (in accordance with RECIST v1.1)
  4. BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
  5. ECOG-PS score 0 or 1
  6. Child-Pugh Class: Grade A
  7. Life Expectancy of at least 12 weeks
  8. 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
  9. Subjects with HCV-RNA(+) must receive antiviral therapy
  10. Adequate organ function


Exclusion Criteria:

  1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
  2. Moderate-to-severe ascites with clinical symptoms
  3. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
  4. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
  5. Known genetic or acquired hemorrhage or thrombotic tendency
  6. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
  7. Cardiac clinical symptom or disease that is not well controlled
  8. Hypertension that can not be well controlled through antihypertensive drugs
  9. Factors to affect oral administration
  10. History of hepatic encephalopathy
  11. Previous or current presence of metastasis to central nervous system
  12. HIV infection
  13. Combined hepatitis B and hepatitis C co-infection
  14. Be ready for or previously received organ or allogenic bone marrow transplantation
  15. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
  16. Active known, or suspected autoimmune disease
  17. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
  18. Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
  19. Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
  20. Severe infection within 4 weeks prior to the start of study treatment
  21. 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
  22. Treatment of other investigational product(s) within 28 days prior to the start of study treatment

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Locally Advanced or Metastatic and Unresectable HCC

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Jul 31, 2023

Treatment type



Jiangsu HengRui Medicine Co., Ltd. identifier


Study number


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