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

Completed · Phase 3

Conditions studied: Locally Advanced or Metastatic and Unresectable HCC

In brief

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.

Key facts

Study ID

NCT03764293

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

543

Starts

2019-06-10

Expected to finish

2023-06-14

Last updated by the study team

2024-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• University of California San Diego (UCSD)-Moores Cancer Center — La Jolla, California, United States
• University of California - Irvine — Orange, California, United States
• University of Maryland — Baltimore, Maryland, United States
• Cornell University Weill Cornell Medical College — New York, New York, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Renovatio Clinical — The Woodlands, Texas, United States
• Cliniques Universitaires de Bruxelles Hopital Erasme — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• UZA — Edegem, Belgium
• AZ Maria Middelares — Ghent, Belgium
• AZ Groeninge — Kortrijk, Belgium
• Anhui Provincal Cancer Hospital — Hefei, Anhui, China
• Anhui Provincal Hospital — Hefei, Anhui, China
• The First Affiliated Hospital Of Anhui Medical University — Hefei, Anhui, China
• The Second Affiliated Hospital Of Anhui Medical University — Hefei, Anhui, China
• Chinese Academy of Medical Sciences Cancer Hospital — Beijing, Beijing Municipality, China
• Beijing cancer Hospital — Beijing, Beijing Municipality, China
• Peking University International Hospital — Beijing, Beijing Municipality, China
• The Second Hospital Affiliated To AMU — Chongqing, Chongqing Municipality, China
• The First Hospital Affiliated To AMU — Chongqing, Chongqing Municipality, China
• TheThird Affiliated Hospital ,Army Medical University — Chongqing, Chongqing Municipality, China
• The Second Affiliated Hospital of ChongQing Medical University — Chongqing, Chongqing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Beverly Hills Cancer Center — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.