Recurrent hepatocellular carcinoma
Conditions
Interventions
Interventional group:Sintilimab+ bevacizumab
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Between the ages of 18 and 80, regardless of gender; 2) ECOG score: 0-1; 3) The clinical diagnosis was consistent with recurrent hepatocellular carcinoma, and the lesion was consistent with the indications of operable resection in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) a. Intraoperative gross and postoperative imaging and pathology confirmed complete resection without residual cancer; b. No hepatic vein, portal vein, inferior vena cava or bile duct invasion outside the resection scope; c. Negative incisal margin: pathological confirmation, no lymph node invasion, no distant metastasis; 4) There was at least one radiologically measurable lesion according to mRECIST; 5) Have one of the following risk factors for recurrence (preoperative prediction of positive MVI; =2 lesions; Lesion diameter =5cm; Imaging evaluation of the tumor showed no significant boundary or envelope. Serological AFP= 400ng/mL; Tumor thrombus formation in the resection area) 6) Preoperative liver function assessment of Child-Pugh grade A or B, if HBsAg positive patients, HBV-DNA < 200,000 IU/ml (10^6 copies /ml), conventional antiviral treatment; Good coagulation function (INR =2.3). Gastroscopy esophageal vein without severe varicosity, no active digestive tract ulcer. No hepatic encephalopathy or/and moderate or above ascites. Renal function and cardiopulmonary function are basically normal. Hemoglobin =90g/L, white blood cell count =3.0×109/L, neutrophil count =1.5×109/L, platelet count =60×109/L, no definite cachexia; 7) Expected life expectancy is greater than three months, no pregnancy, no HIV or syphilis infection, can understand the situation of the study and signed an informed consent.
Exclusion criteria
Exclusion criteria: 1) The interval between the recurrence time and the previous operation is less than 1 year. 2) History of other malignant tumors within 5 years or at the same time 3) Distant metastasis has occurred, such as metastasis to lung, brain, bone, etc 4) Patients with imaging findings showing the formation of blood vessels and/or cholangiocarcinoma thrombus outside the scope of resection and who cannot be treated with R0 resection. 5) Received any targeted, immune, interventional and radiotherapy before enrollment (such as Renvastinib, PD1, PD-L1 and other drugs) 6) Severe varicose esophagus and gastric fundus veins, prone to gastrointestinal bleeding, or previous history of massive gastrointestinal bleeding; 7) Patients with incomplete function of important organs. Oral administration of warfarin and other anticoagulant drugs within 2 weeks. 8) Researchers believe that participants should not participate in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Adverse drug reaction;Surgical complications and safety;Disease Free Survival;overall survival rate; | — |
Countries
China
Contacts
Public ContactShuqun Cheng
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed