hepatocellular carcinoma
Conditions
Interventions
Control group:Placebo
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, no gender limit; 2. Radical resection was performed, primary hepatocellular carcinoma was pathologically confirmed, and intraoperative and postoperative radical resection criteria were achieved; 3. Meet any of the following risk factors for postoperative recurrence: microvascular invasion (MVI); Tumor size > 5cm; The number of tumors > 3; Hepatocyte Edmondson-Steiner grading was grade III or IV. The above risk factors for recurrence were assessed based on preoperative imaging and postoperative pathological findings; 4. Subjects with CNLC stage Ia, Ib, ?a or ?b, and BCLC stage 0, A or B; 5. ECOG PS score within 1 week before randomization: 0-1 score; 6. Had not received antitumor therapy for liver cancer before randomization, including systemic therapy and local therapy, except radical resection for primary hepatocellular carcinoma and adjuvant TACE allowed by this program; 7. Child-Pugh liver function rating: A or B; 8. Subjects undergoing radical resection may choose to receive one TACE treatment 4-6 weeks after surgery, and have fully recovered from TACE surgery to meet the following criteria within the first 4 weeks of randomization: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=5x upper limit of normal range (ULN); Total bilirubin <=3xULN; Symptoms of the syndrome (such as fever, nausea, vomiting and abdominal pain) recovered to CTCAE Grade 1 after embolization. No serious medical events (e.g. gastrointestinal bleeding, cardiac events, hepatorenal syndrome) occurred during or after the TACE procedure; 9. Subjects were randomized 4-12 weeks after radical surgery for primary hepatocellular carcinoma; 10. Women of childbearing age must have had a negative pregnancy test (serum) within 7 days prior to randomization and be willing to use adequate contraception from the date of signing the informed consent; Men of childbearing age must agree to use adequate contraception from the time they sign an informed consent form; The time limit was 3 months from the signing of the informed consent to the last medication; 11. If a subject is infected with hepatitis B virus (HBV) : Hepatitis B surface antigen (HBsAg) positive subjects received anti-HBV therapy for at least 14 days prior to randomization and are willing to receive antiviral therapy throughout the study period (according to treatment guidelines) and be monitored regularly; Hepatitis C virus (HCV) RNA positive subjects should receive antiviral therapy according to the guidelines and liver function should be CTCAE level 1 or less; 12. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who are afraid of cold limbs; 2. Imageological or pathological indications of concomitant invasion of great vessels, or macroscopic cancer embolus visible during surgery; 3. Patients with extrahepatic metastasis; 4. The pathology suggested intrahepatic cholangiocarcinoma, mixed cell carcinoma and fibrolaminar cell carcinoma; 5. Previous recurrence of liver cancer, or any hepatectomy prior to radical resection; 6. Received two or more TACE treatments after surgery; 7. Received or prepared to receive radiotherapy, chemotherapy, molecular targeting agents, biotherapy, TACE, radiofrequency ablation, traditional Chinese medicine and other anti-liver cancer therapies before, perioperative and postoperative radical hepatectomy (except postoperative TACE adjuvant therapy as prescribed by the protocol); 8. Any evidence of tumor metastasis or concurrent malignant disease; 9. Plans for a future liver transplant; 10. Other malignant tumors (except cured basal cell carcinoma of the skin, carcinoma in situ of the prostate, carcinoma in situ of the cervix, superficial bladder tumors [Ta, Tis, T1], and carcinoma in situ/precancerous lesions of the digestive tract) within 5 years; 11. Significantly abnormal liver and kidney function, meeting any of the following criteria: alkaline phospholipase (ALP) > 2.5 times the upper limit of normal, serum albumin (ALB) 1.5 times the upper limit of normal; 12. Routine neutrophil count (Neutrophil) =40g/d, female >=20g/d, or two weeks of heavy drinking history, equivalent to alcohol amount >80g/d) (ethanol amount (g) conversion formula: Alcohol consumption (m1)× ethanol content (%)×0.8) and/or psychoactive substance, drug abuse and dependence; 19. Patients who received COVID-19 vaccination within 2 weeks prior to screening; 20. Participated in other clinical trials within 4 weeks prior to screening; 21. The investigator did not consider it appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survival at the end of the year as assessed by blind independent center review (BICR); | — |
Secondary
| Measure | Time frame |
|---|---|
| The 1-year recurrence-free survival rate assessed by BICR;Relapse-free survival (RFS) at year 1 and year 2 as assessed by the investigator;RFS assessed by BCIR and investigator;Time to relapse as assessed by BICR and the investigator;Overall survival;Survival rates at the end of one year and two years;Child-Pugh score of liver function at the end of 1 year and 2 years;Serum AFP;ECOG;EORTC Quality of Life Measurement Scale QLQ-C30;EORTC QLQ-HCC18; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed