Primary liver cancer
Conditions
Interventions
Sponsors
Cancer Hospital Affiliated to Guangxi Medical University
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, regardless of gender; 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 (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with other active malignant tumor except liver cancer within 1.5 years or at the same time. 2. Patients with extrahepatic metastasis; 3. Patients with moderate or severe ascites with clinical symptoms, i.e. those who need therapeutic puncture and drainage, or uncontrolled or medium or above pleural effusion and pericardial effusion; 4. Patients without other anti-tumor treatment within 4 weeks before enrollment, including surgical treatment, local treatment and systemic treatment; 5. Patients with active autoimmune disease or history of autoimmune disease and may relapse; 6. Patients with important cardiovascular diseases, such as heart disease (grade II or higher) defined by the New York Heart Association, myocardial infarction, unstable arrhythmia and unstable angina pectoris within 3 months before randomization; 7. Subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; 8. Patients with active pulmonary tuberculosis; 9. Patients with active clinical severe infection (> grade 2 nci-ctcae version 5.0), except HBV and HCV infection; 10. Patients with uncontrolled hypertension; 11. Patients with any contraindications or severe allergic reactions to cindilimab, sorafenib, raltitrexed, and lobaplatin; 12. Patients with a history of gastrointestinal hemorrhage or a clear tendency of gastrointestinal bleeding in the past 6 months, such as esophageal varices with bleeding risk, local active ulcer lesions, and fecal occult blood >= + +, are not allowed to be included; 13. Patients with thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis or pulmonary embolism within 6 months before the first administration of the study drug; 14. Patients with known HIV infection history; 15. Patients who have previously received immunosuppressive therapy; 16. The researcher judges other situations that may affect the clinical study and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse reactions; | — |
Countries
China
Contacts
Public ContactFeixiang Wu
Cancer Hospital Affiliated to Guangxi Medical University
Outcome results
None listed