Hepatocellular carcinoma
Conditions
Interventions
Experiment Group:Arterial Infusion of Camrelizumab
Experiment Group:Arterial Infusion of mFOLFOX
Experiment Group:Oral intake of Sorafenib
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Clinical diagnosed of hepatocellular carcinoma according to the "Guidelines for the Diagnosis and Treatment of hepatocellular carcinoma (2019 Edition)" formulated by the National Health Commission and the EASL liver cancer guidelines, and pathological confirmed of hepatocellular carcinoma; b) Cannot be surgically removed, and there is at least one assessable lesion in the liver; c) BCLC staging is C stage, with vascular/biliary invasion or extrahepatic metastasis; d) The first visit did not receive other treatment; e) ECOG PS score 0 or 1 point; f) No history of autoimmune diseases; g) Willing to adopt the treatment plan. h) The life expectancy exceeds 3 months. i) Complete preoperative imaging examination results, including chest CT, upper abdominal CT/MRI plain scan and enhanced j) Laboratory inspection meets the following standards: Neutrophils >= 1.5*10^9/L White blood cell >= 3.0*10^9/L Platelet >= 75*10^9/L Hemoglobin >= 80g/L Serum ALT, AST = 30g/L Total bilirubin <= 1.5 * ULN.
Exclusion criteria
Exclusion criteria: a) Have previously received ablation therapy or vascular interventional therapy; b) Have previously received anti-PD-1 antibody therapy or other immunotherapy; c) Previously received targeted therapy or traditional Chinese medicine (such as oral sorafenib or Huaier granules); d) PS score >= 2 points; e) Child-Pugh score>=10 points, namely C level; f) Decompensation of liver function, such as massive ascites, gastric esophageal varices and upper gastrointestinal bleeding within 1 year, hepatic encephalopathy, bilirubin encephalopathy; g) With brain metastases or bone metastases that require emergency intervention by surgery or radiotherapy; h) Pregnant or suspected pregnancy, or breastfeeding; i) History of HIV infection; j) With a history of other malignant tumors. k) Peripheral blood neutrophil absolute value < 1.0 * 10^9/L or hemoglobin<90g/L or total number of platelets < 50 * 10^9/L caused by hypersplenism. l) Any of the following conditions occurred 12 months before the start of the study: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular, pulmonary embolism. m) Patients with renal insufficiency requiring dialysis. n) Past transplant history. o) The patient has other serious acute, chronic physical or mental diseases or abnormal laboratory tests, which may increase the risk of the study, or interfere with the interpretation of the results that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival Time (PFS);Overall survival Time (OS); | — |
Countries
China
Contacts
Public ContactWeijun Fan
Sun Yat-Sen University Cancer Center
Outcome results
None listed