Primary liver cancer
Conditions
Interventions
Group 1:TACE
Group:HAIC
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient must sign the informed consent and be willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study schedule; 2. Patients aged 18-70 years old; 3. Hepatocellular carcinoma was diagnosed by histopathology; (1) Patients with HCC after R0 resection were confirmed by histopathology after reading the film by independent pathology center Postoperative pathological report should be provided); There was no residual tumor in operation or after operation; There was no invasion of bile duct and portal vein; (2) For patients with hepatocellular carcinoma, there is one of the following risk factors for recurrence: Single lesion, diameter > 5 cm; Single lesion, 3-5 cm in diameter, with postoperative pathological diagnosis of microvascular invasion (MVI) M1/M2; Single lesion, diameter < 3cm, accompanied by microscopic venous microvascular invasion (MVI) m2; More than 3 lesions; 4. Preoperative assessment of patients without extrahepatic metastasis; 5. The residual liver volume should be more than 40% of the standard liver volume (cirrhosis patients), or more than 30% of the standard liver volume (patients without liver cirrhosis); ICG R15 < 20%; 6. Patients without adjacent organs invasion, hilar lymph node or distant metastasis; 7. Patients with ECoG score of 0-1; 8. Child Pugh a ~ B grade; 9. If HBsAg (+) and / or HBcAb (+), HBV DNA must be < 2000 IU / ml, and anti HBV treatment should be conducted during the study period, or entecavir should be used throughout the study. If HCV antibody test results are positive, it is up to the researcher to decide whether to give antiviral treatment; 10. Women of childbearing age must have serum pregnancy test, and the result is negative; 14. Patients who have fully understood and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Having other active malignant tumors other than liver cancer within 5 years or at the same time; 2. The presence of extrahepatic metastasis; 3. Moderate or severe ascites with clinical symptoms, i.e., those requiring therapeutic puncture and drainage; Or uncontrolled or moderate pleural effusion or pericardial effusion; 4. No other anti-tumor treatment, including surgical treatment, local treatment and systematic treatment, was received within 4 weeks before enrollment; 5. Important cardiovascular diseases, such as heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction, unstable arrhythmia, unstable angina, occurring randomly within the first 3 months; 6. Active tuberculosis; 7. Active clinical severe infection (> level 2 nci-ctcae version 5.0), except HBV and HCV infection; 8. Uncontrolled high blood pressure; 9. Known or suspected allergy to any drug associated with the trial 10. Have a history of gastrointestinal bleeding or have a clear tendency of gastrointestinal bleeding in the past 6 months, such as: esophageal varices with bleeding risk, locally active ulcer lesions, fecal occult blood = (++) cannot be included in the group; 11. Occurrence of a thrombotic or embolic event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, within 6 months prior to the first administration of the study drug; 12. Known history of HIV infection; 13. The investigator determines other conditions that may influence the conduct of the clinical study and the determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS;OS rate;AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;RFS rate; | — |
Countries
China
Contacts
Public ContactFeixiang Wu
Guangxi Medical University Cancer Hospital
Outcome results
None listed