Advanced Hepatocellular Carcinoma (HCC)
Conditions
Interventions
Product Name: Camrelizumab
Product Code: SHR-1210
Pharmaceutical Form: Injection
INN or Proposed INN: CAMRELIZUMAB
CAS Number: 1798286-48-2
Current Sponsor code: SHR-1210
Concentration unit: mg millig
Sponsors
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - = 18 years old, male and female - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 153
Exclusion criteria
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 or other gastrointestinal disorder with risk of bleeding - 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 - 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/CYP2C19 inducers or inhibitors within 14 days prior to the start of study treatment - Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product as SHR-1210, rivoceranib , sorafenib or other mAbs - 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 or 5 half-lives (whichever comes later) prior to the start of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To compare the efficacy of SHR-1210 combined with rivoceranib versus sorafenib through evaluations of PFS, time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). • To evaluate the safety of SHR-1210 combined with rivoceranib mesylate versus sorafenib. • To evaluate PK of SHR-1210 and rivoceranib and immunogenicity of SHR-1210.;Primary end point(s): Overall survival (OS) and PFS;Timepoint(s) of evaluation of this end point: For the OS endpoint, it will be evaluated from randomization to death from any cause For PFS endpoint, it will be evaluated from randomization to the occurrence of disease progression or death from any cause;Main Objective: To compare the overall survival (OS) and progression-free survival (PFS) of SHR-1210 plus rivoceranib versus sorafenib | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) and PFS • Incidence and severity of adverse event (AE) and serious adverse event (SAE) judged in accordance with NCI-CTCAE v4.03; vital signs, ECG, and abnormal laboratory examinations; • Serum concentration of SHR-1210 and plasma concentration of rivoceranib; proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline; analysis of the immunogenicity of SHR-1210 in combination with the concentration of SHR-1210.;Timepoint(s) of evaluation of this end point: ORR and DCR will be evaluated from randomization until last tumor assessment PFS will be evaluated from randomization to the first occurrence of disease progression or death from any cause TTP will be evaluated from the date of randomization to the date of the first documented tumor progression DOR will be evaluated From the first occurrence of a documented objective response to disease progression or death from any cause | — |
Countries
Belgium, China, Germany, Hong Kong, Italy, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactYing Liang
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Outcome results
None listed