| Eligibility |
Inclusion Criteria:
- Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology;
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C;
- ECOG performance status: 0-1;
- Child Pugh score=7;
- Enough organ function;
- Has at least one measurable lesion based on RECIST 1.1;
- Life expectancy =3 months;
- Patients must be able to understand and willing to sign a written informed consent
document;
Exclusion Criteria:
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma,
cholangiocarcinoma etc;
- Past or present hepatic encephalopathy; or Budd-Chiari syndrome; or Tumor thrombus
invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
- Subjects who have previously received immune checkpoint inhibitors (such as
anti-PD-1/L1, CTLA-4, etc.); or have a history of = grade 3 immune-related adverse
reactions; or hyperprogressive after immunotherapy previously;
- Subjects who have received liver local treatment (transcatheter chemoembolization,
transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization
or ablation) within 4 weeks before administration;
- Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
- Any previous or current active autoimmune disease or history of autoimmune disease;
- History of liver transplantation;
- History of interstitial lung disease or non-infectious pneumonia;
- History of allergic reactions to related drugs;
- LVEF< 50% or LLN
- Clinically obvious gastrointestinal abnormalities, which may affect the intake,
transport or absorption of drugs (such as inability to swallow, chronic diarrhea,
intestinal obstruction, etc.), or patients undergoing total gastrectomy;
- With serious systemic diseases such as heart disease and cerebrovascular disease, and
the condition is unstable or uncontrollable;
- Subjects with clinically significant gastrointestinal bleeding or thrombosis or
embolic events within 6 months;
- Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA>
1000copy/ml, both HbsAg and anti-HCV body are positive;
- Evidence of active pulmonary tuberculosis (TB);
- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS);
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing
drainage;
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