Hepatocarcinoma
Conditions
Interventions
case series:Nil
Sponsors
Shandong Province Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent and be able to comply with the visits and related procedures set out in the programme. 2. Ages between 18 to 75 years. 3. Patients initially diagnosed as hepatocellular carcinoma according to the diagnostic criteria of China Primary Liver Cancer Diagnosis and Treatment Regulations (2019 edition), and received a radical resection. 4. Pathology confirms complete resection (recovery from surgery to be disease-free, and the sample has negative R0 margins), and the pathological stage is at stage IIb, IIIa, and IIIb. 5. Patients confirmed in disease-free status at least 4 weeks after surgery by imaging examination before randomization. 6. Patients with either being of high risk of recurrence: i. with at least 2 following characteristics: the largest tumor diameter > 5cm; > 3 tumors; microvascular invasion (MVI); poor pathological differentiation (G3 or G4); preoperative AFP >= 400ng/ml. ii. Gross vascular tumor thrombus. 7. Patients with Grade A of Child-Pugh. 8. Patients with 0-2 points ECOG score. 9. Patients not received any anti-tumor treatment before radical resection of liver cancer. 10. Expected survival time greater than 6 months 11. Organs and bone marrow function well. The laboratory test within 14 days before randomization meets the following requirements (it is not allowed to meet the conditions by giving any blood components, cell growth factors, albumin and other treatment drugs, except for hemoglobin). Details as follows. iii. Blood tests: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet (PLT) >= 75 x 10^9/L; Hemoglobin (HGB) >= 9.0 g/dL. iv. Liver function tests: Total bilirubin (TBIL) = 28 g/L; Alkaline phosphatase (ALP) = 50mL/min (Cockcroft-Gault); Protein in Urine <2+ or Protein in Urine in 24 hours <1g. vi. Coagulation tests: International normalized ration (INR) <= 1.5ULN; Activated Partial Thromboplastin Time (APTT) <= 1.5ULN. 12. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with known fibrous lamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma HCC. 2. HCC recurring before randomization. 3. Patients with the history of organ transplantation or hepatic encephalopathy. 4. Patients with any evidence of residual tumor, cancer recurrence or metastasis. 5. Patients with uncontrollable pleural fluid, ascites, pericardial effusion. 6. Patients with tumor thrombus in main portal vein, inferior vena cava and hepatic vein first-level branch or above, bile duct first-level branch or above. 7. Patients with severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy. 8. Patients with uncontrollable hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure> 90 mmHg after the best medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 9. Patients with symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia. 10. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA > 10^3 copies/ml; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive at the same time. 11. Patients with severe infections that are active or poorly clinically controlled. Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia. 12. Patients receiving Chinese traditional medicines with anti-tumor indications within 2 weeks before the start of the study treatment, or receiving drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural fluid or ascites). 13. Patients with serious or uncontrollable systemic diseases such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver and kidney diseases, or uncontrolled/uncorrectable metabolic disorders or other non- Malignant tumor organ disease or systemic disease or cancer secondary reaction, which may lead to higher medical risk and/or uncertainty in survival evaluation. 14. Patients diagnosed as other malignant tumors within 5 years before the start of the study treatment, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically resected carcinoma in situ. If other malignant tumors are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions is required. 15. Patients receiving treatments from other clinical trials within 4 weeks before the start of the study treatment. 16. Female patients who are pregnant or breastfeeding. 17. Patients with other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may cause the following results: increase the risk associated with research participation, or interfere with the interpretation of research results, and according to the judgment of the researcher, the patient is classified as not eligible to participate in this research Qualifications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Yearly Ratio of Recurrence Free Survival;Time to Recurrence; | — |
Countries
China
Contacts
Public ContactLei Zhao
Shandong Province Cancer Hospital
Outcome results
None listed