unresectable advanced liver cancer
Conditions
Interventions
test team::HAIC/HAIC + PD-1 inhibitors combined with anti-vascular targeting agents
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, male and female; 2. Patient's ECOG PS score = 1; 3. Primary hepatocellular carcinoma confirmed by clinical and imaging, histology or cytology, without lymph node or extrahepatic metastasis; 4. Definition of non-surgical resection (conforming to one of the following): 1) The volume of single tumor accounts for more than 50% of the liver volume, and the remaining liver is less than 30% of the normal liver volume or the remaining liver weight/body weight is less than 5%; 2) Multiple tumors (>3) distributed in the left and right liver, and the maximum diameter of the lesions was greater than 4 cm (beyond the up to 7 standard); 5. The case was considered inoperable by the expert group of liver surgery after collective discussion; 6. No contraindication of HAIC or TACE treatment; 7. Primary patients with at least one intrahepatic lesion measurable (Modified RECIST standard 27); 8. No cirrhosis or Child-Pugh class A cirrhosis, no ascites, no obvious liver atrophy; 9. There is no serious damage to liver and kidney function, and the organ function level must meet the following requirements: neutrophil = 1500/ µ L Platelet = 60000/ µ L Hemoglobin>8.5 g/dL; Plasma albumin>3.0 g/dL; Total bilirubin<30mmol/L; ALT and AST are lower than 5 times the normal upper limit; INR<1.7 or PT extension not more than 4 seconds; Blood creatinine is lower than 1.5 times the upper limit of normal. 10. The patient knows the condition and signs the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Within 5 years or at the same time suffering from other active malignant tumors except liver cancer. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group; 2. There is extrahepatic metastasis; 3. Moderate and severe ascites with clinical symptoms, that is, those who need therapeutic puncture and drainage; Or uncontrolled or moderate or more pleural effusion and pericardial effusion; 4. Have received organ or allogeneic bone marrow transplantation; 5. Active autoimmune disease or history of autoimmune disease and possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [only subjects that can be controlled by hormone replacement therapy can be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma patients who need bronchodilators for medical intervention cannot be included; 6. Subjects who require systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the administration of the study drug; 7. Subjects with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc., which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; 8. Active clinical severe infection (>Level 2 NCI-CTCAE Version 5.0), excluding HBV and HCV infection; 9. Cardiac clinical symptoms or diseases that cannot be well controlled, such as: (1) Cardiac insufficiency or cardiac color Doppler ultrasound examination above grade II according to the New York Heart Association (NYHA) standard: LVEF (left ventricular ejection fraction)450ms (male); QTc>470ms (female) (QTc interval is calculated by Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken); 10. Uncontrolled hypertension; 11. Any contraindication or severe allergic reaction; 12. Have a history of gastrointestinal bleeding disease or have a clear tendency of gastrointestinal bleeding within the past 6 months, such as esophageal varices with bleeding risk, local active ulcer focus, stool occult blood = (++) can not be included in the group; 13. Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred within 6 months before the first administration of the study drug; 14. Known history of HIV infection; 15. Pregnant women or lactating subjects; 16. The investigator judges other situations that may affect the clinical research and the judgment of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective mitigation rate;Surgical resection rate; | — |
Countries
China
Contacts
Public ContactShan RenFeng
The First Affiliated Hospital of Nanchang University
Outcome results
None listed