Status:
COMPLETED
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Locally Advanced or Metastatic and Unresectable HCC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT03764293
Start Date
June 10 2019
End Date
June 14 2023
Last Update
February 6 2024
Active Locations (121)
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1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
2
University of California San Diego (UCSD)-Moores Cancer Center
La Jolla, California, United States, 92037
3
University of California - Irvine
Orange, California, United States, 92868
4
University of Maryland
Baltimore, Maryland, United States, 21201