Hepatocellular carcinoma
Conditions
Sponsors
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any testing related processes 2. Male or female = 18 years old, = 70 years old 3. Confirmed by histology or cytology as hepatocellular carcinoma or clinically diagnosed as primary liver cancer, unable to undergo surgical resection 4. Molecular typing: molecular detection of relevant targets: TMB, MSS, MMR, FGFR2, IDH1/2, HER-2, KRAS, TP53, PD-L1, selecting HCC patients with TP53 mutations 5. Patients who have previously undergone second-line anti-tumor treatment and have progressed in their condition 6. Expected survival time>3 months 7. At least 1 measurable lesion according to RECIST 1.1 standard 8. Karnofsky Functional Status Score (KPS) score = 60 points 9. Sufficient organ function is required for the subject to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) = 1.5x109/L without the use of granulocyte Colony-stimulating factor in recent 14 days; 2) Platelets = 90 without blood transfusion in the past 21 days × 109/L; 3) Hemoglobin>9g/dL without blood transfusion or use of erythropoietin in the past 21 days; 4) Total bilirubin = 3 × Upper limit of normal value (ULN); 5) Asparagus cochinchinensis Transaminase (AST), alanine Transaminase (ALT) = 2.5 × ULN (ALT or AST = 5 allowed for patients with liver metastasis) × ULN); 6) Alkaline phosphatase (AKP) = 2.5 × ULN 7) Creatinine clearance rate (calculated using the Cockcroft Fault formula) = 50 ml/min; 8) Good coagulation function, defined as international standardized ratio (INR) or Prothrombin time (PT) = 1.5 times ULN; 9) Normal thyroid function, defined as Thyroid-stimulating hormone (TSH = 10) within the normal range; If there is no clinically significant thyroid dysfunction after Thyroid hormones supplementation, they can also be included in the group. 10) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that a simple laboratory abnormality without clinical significance is also allowed to be included); 10. Female subjects of childbearing age should receive urine or serum Pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the urine Pregnancy test result cannot be confirmed as negative, a blood Pregnancy test is required. Women of non childbearing age are defined as at least 1 year after menopause, or having undergone surgical sterilization or Hysterectomy 11. If there is a risk of conception, all participants (whether male or female) are required to sign written informed consent for the use of contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period and up to 120 days after the last study drug administration. Prior to the implementation of any trial related procedures, written informed consent is required 12. Willing to accept this treatment plan
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases diagnosed as liver cancer within 5 years before the first administration (excluding Basal-cell carcinoma of skin, squamous cell carcinoma of skin, and/or Carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection); 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3. Active autoimmune diseases requiring systemic Sex therapy (such as the use of disease relieving drugs, glucocorticoids or Immunosuppressive drug) occurred before the first administration. Alternative therapy (such as Thyroxine, insulin or physiological glucocorticoid used for adrenal or pituitary insufficiency) is not considered as systemic Sex therapy. A known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm the presence of autoimmune diseases based on the judgment of researchers; 4. People who are known to be allergic to Sintilimab and Arsenic trioxide ingredients or excipients 5. Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. = level 1 or reaching baseline, excluding fatigue or hair loss) 6. Known history of HIV (HIV) infection (i.e. HIV 1/2 antibody positive) 7. Except for COVID-19 vaccine, which has been inoculated with live attenuated vaccine within 4 weeks before the first administration 8. Pregnant or lactating women 9. There are any serious or uncontrollable systemic diseases, such as: 1) There are serious and uncontrollable abnormalities in rhythm, conduction or morphology of resting ECG, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or Atrial fibrillation; 2) Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) rating of = 2; 3) Have experienced any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment for treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; 4) Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures have been performed within 4 weeks prior to the first administration. Have received tissue biopsy or other minor surgery within 7 days before the first administration, except for Venipuncture catheterization for intravenous infusion 5) Poor blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 6) Active pulmonary tuberculosis; 7) Active or uncontrolled infection requiring systemic Sex therapy; 8) There were clinical active Diverticulitis, abdominal abscess, gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poor control of diabetes (Glucose test#Fasting blood sugar (FBG)>10mmol/L); 11) Urinary routine examination indicates that urine protein is =++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0g; 12) Patients with mental disorders who are unable to cooperate with treatment; 10. Medical history or evidence of illness, abnormal treatment or laboratory test values that may interfere with the experimental results, hinder the full participation of the subjects in the study, or other situations that the researcher believes are not suitab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate ;progression-free survival ;overall survival ;Quality of life;Safety and tolerability ; | — |
Countries
China
Contacts
Public ContactWan Xuying
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Outcome results
None listed