Hepatocellular carcinoma
Conditions
Interventions
Surgery/RFA:After discontinuing the dual drugs for 6 weeks (with one dose of Bevacizumab analogs administered during this period), radical resection or radiofrequency ablation of hepatocellular carcin
regular follow-up is performed.
Continuous drug treatment.:Continuous treatment with the dual drugs (Sintilimab 200mg + Bevacizumab analog 15mg/kg, administered via intravenous infusion, once every 3 weeks)
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign an informed consent form; 2. Age is between 20 and 75 years old, with no gender restriction; 3. Clinically diagnosed or pathologically confirmed intermediate or advanced hepatocellular carcinoma (BCLC-B/C), which has been downgraded to BCLC stage A (according to RECIST 1.1 criteria) after treatment with TACE in combination with the dual drugs; 4. Liver function Child-Pugh score =12 weeks; 7. Important organ functions meet the following requirements (no use of any blood components (such as albumin), cell growth factors, and other corrective therapeutic drugs within 14 days prior to evaluation): (1) Hemoglobin >= 90g/L; (2) Neutrophil count >= 1.5×10^9/L; (3) Platelet count >= 60×10^9/L; (4) Serum albumin >= 30g/L; (5) Total bilirubin 2000 copies/mL, start taking oral antiviral drugs at least one week in advance; 9. For non-surgically sterilized or women of childbearing age, they need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pills, or condoms) during the research treatment and within three months after the end of the treatment. For non-surgically sterilized women of childbearing age, a serum or urine HCG test must be negative within 72 hours before joining the study; moreover, they must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Previous use of other targeted, immune or chemotherapy drugs other than the dual approach; previous local treatment for liver cancer such as radiofrequency, surgery, or radiotherapy; 2. Patients with clinically symptomatic ascites that require puncture, continuous drainage, or those who have received ascites drainage in the past three months, except those who only have a small amount of ascites shown by imaging but are without clinical symptoms; 3. Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure of more than grade 2, unstable angina; (2) Myocardial infarction in the past year; (3) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (4) Severe hyperthyroidism or hypothyroidism patients. 4. Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or currently receiving thrombolysis or anticoagulant treatment, preventive use of low-dose aspirin, low-molecular-weight heparin, etc., is allowed; 5. Significant clinically significant bleeding symptoms in the past three months before randomization or a clear tendency to bleed, such as gastrointestinal bleeding, esophageal varices with a risk of bleeding, bleeding gastric ulcers or patients with vasculitis, etc. If there is positive occult blood in the stool at baseline, re-examination is needed, and if it does not turn negative, gastroscopy and colonoscopy are needed. If gastroscopy indicates severe esophagogastric varices with red signs, the patient cannot be enrolled; 6. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); 7. Urinalysis suggests urine protein >= ++ and 24-hour urine protein >1.0g is confirmed; 8. Patients who have previously received hormone therapy and it is less than four weeks before the use of research drugs after the treatment is completed (last dose); patients whose adverse events caused by previous treatment (except hair loss) have not recovered to = 38.5°C within 7 days before drug use, or a white blood cell count >= 15*10^9/L at baseline; 10. HCV, HIV or syphilis infection; 11. Patients with other malignant tumors within the past three years or at the same time; 12. Patients who have long suffered from headaches or migraines and cannot be relieved by medication; 13. Patients who, for other reasons considered by the researchers, should not participate in this trial, such as severe mental illness, drug abuse, family or social factors unsuitable for enrollment, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to reatment failure;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactShuqun Cheng
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed