| Eligibility |
Inclusion Criteria:
- Sign a written informed consent form prior to enrollment;
- Age was 18-75 years old;
- Hepatocellular carcinoma (HCC) was confirmed by imaging or histology or cytology;
- Patients with stage C and B unresectable BCLC stage (either with portal cancer emboli
including VP1-3, but not enrolled if the main portal cancer embolus completely blocked
blood vessels and had no blood flow passage)
- With measurable foci (non-lymph node lesion CT scan long diameter = 10 mm, lymph node
lesion CT scan short diameter = 15 mm according to RECIST 1.1 criteria);
- Has never previously received any antitumor system treatment, especially the
immunotherapy;
- ECOG score: 0~1;
- Child-Pugh score = 7;
- Have adequate organ function;
- Estimated survival period of = for 3 months;
Exclusion Criteria:
- Previously diagnosed by histology/cytology with fibrolamellar hepatocellular
carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other
components.
- The patient has suffered from other malignant tumors in the past or at the same time.
- Patients who have received systemic anti-tumor therapy in the past;
- For HCC lesions =10cm in any dimension, there are more than 10 lesions evaluated by
imaging or HCC lesions account for =50% of the liver volume;
- Is a current candidate for liver transplantation or has experienced liver
transplantation;
- There is a risk of bleeding, or coagulation dysfunction, or is undergoing thrombolytic
therapy; or has had bleeding from esophageal or gastric varices in the past 6 months;
- Portal vein tumor thrombus Vp4.
- The patient is known to have been allergic to macromolecular protein preparations or
applied drug components;
- The patient has any active autoimmune disease or a history of autoimmune disease (such
as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,
uveitis, enteritis, hypophysitis, vasculitis, nephritis Patients with abnormal thyroid
function (hyperthyroidism/decreased thyroid function), and the use of drugs cannot
maintain thyroid function in the normal range, or previous thyroid surgery, patients
who need long-term thyroxine and other drug replacement therapy after surgery; the
patient has Vitiligo or asthma has been completely relieved in childhood, and those
without any intervention after adulthood can be included; asthma whose patients
require medical intervention with bronchodilators cannot be included)
- The patient is using immunosuppressive agents, or systemic or absorbable local hormone
therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other
curative hormones), and within 2 weeks before enrollment Still in use;
- The patient is still using traditional Chinese medicine or other immunomodulators
within 2 weeks before enrollment;
- Ascites or pleural effusion with clinical symptoms cannot be controlled with drugs and
requires therapeutic puncture or drainage;
- There are clinical symptoms or diseases of the heart that are not well controlled,
such as: (1) Heart failure above NYHA level 2 (2) Unstable angina (3) Myocardial
infarction occurred within 1 year (4) Supraventricular with clinical significance Or
patients with ventricular arrhythmia in need of treatment or intervention;
- Severe infections that are active or poorly clinically controlled. Severe infections
within 4 weeks before the first administration, including but not limited to
hospitalization due to complications of infection, bacteremia or severe pneumonia, or
fever of unexplained occurrence> 38.5 degrees during the screening period and before
the first administration (by research According to the judge, the patient can be
included in the group for fever caused by the tumor);
- Past and current patients with objective evidence of pulmonary fibrosis, interstitial
pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely
impaired lung function, etc.; patients with known syphilis infection requiring
treatment; active tuberculosis ( Active tuberculosis, TB), who are receiving
anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year
before the first administration.
- patients with congenital or acquired immune deficiencies, such as HIV infection, or
active hepatitis (transaminase does not meet the selection criteria, hepatitis B
reference: HBV DNA =2000 IU/ml or =104 copies/ml; hepatitis C reference: HCV RNA=2000
IU/ml or =104 copies/ml; after nucleotide antiviral therapy, it is lower than the
above standard and can be included in the group); chronic hepatitis B virus carriers,
HBV DNA<2000 IU/ml, test During this period, you must receive antiviral treatment at
the same time before you can join the group;
- Live vaccines may be vaccinated during the study period less than 4 weeks before the
study medication;
- The patient is known to have a history of psychotropic drug abuse, alcohol abuse or
drug abuse;
- The investigator believes that it should be excluded from the study. For example, the
investigator judges that the patient has other factors that may cause the study to be
terminated halfway, such as other serious diseases (including mental illness) that
require combined treatment. Serious laboratory abnormalities, accompanied by family or
social factors, can affect the safety of patients or the collection of data and
samples.
- The patient has metastases to the central nervous system.
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