Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Locally Advanced or Metastatic and Unresectable HCC Sorafenib Apatinib SHR-1210

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego (UCSD)-Moores Cancer Center
    La Jolla California 92037 United States
  • University of California - Irvine
    Orange California 92868 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
ID
NCT03764293
Phase
Phase 3 Hepatocellular Carcinoma Research Study
Study Type
Interventional
Participants
At least 543 people participating
Last Updated