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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Locally Advanced or Metastatic and Unresectable HCC

Treatments: Drug: SHR-1210; Drug: Apatinib; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03764293

SHR-1210-III-310

Details and patient eligibility

About

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.

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

543 participants in 2 patient groups

SHR-1210

Experimental group

Description:

SHR-1210+Apatinib

Treatment:

Drug: Apatinib

Drug: SHR-1210

Control

Active Comparator group

Description:

Sorafenib

Treatment:

Drug: Sorafenib