Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Shijiazhuang Ping'an Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Primary hepatocelluar carcinoma comfired by CT/MRI and tumor marker(AFR) combined detection or diagnosed by preoperative puncture pathology; 3. CNLC IIb IIIa and part of IIIb,at least one measurable lesion (according to RECIST 1.1),the lesion reaches a moderate or higher arterial blood supply; 4. No indication of surgical resection or rejection of surgery; 5. The main portal vein is not completely obstructed, or although it is completely obstructed, the compensated collateral vessels of the portal vein are abundant or implanted through the portal vein stent can restore portal vein blood flow; 6. Chlid-Pugh A or B; 7. ECOG PS 0-2; 8. Expected survival period >= 12 weeks; 9.The main organs function normally, met the following criteria: (1) Blood routine examination: 1) HB >= 80 g/L; 2) WBC >= 3.0 x 10^9/L; 3) ANC >= 1.5 x 10^9/L; 4) PLT >= 50 x 10^9/L; (2) Biochemical examination: 1) ALB >= 30 g/L; 2) ALT, AST < 5 x ULN; 3) TBIL <= 3 x ULN; 4) Plasma Cr <= 1.5 x ULN: 10. Left ventriculaor ejection fraction(LVEF)normal low limit (50%); 11. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 12. Participants voluntarily joined the clinical trial, signed the informed consent, good adhereence, and were well-adhereed to follow.
Exclusion criteria
Exclusion criteria: 1. Uncorrectable coagulopathy; 2. Patients with active hepatitis or severe infection who cannot be treated at the same time; patients with chronic hepatitis B are allowed to undergo antiviral treatment, viral (HBV) load is less than 2000 IU/mL or patients infected with hepatitis C virus (HCV) are included; 3. Cachexia or multiple organ failure; 4. The proportion of the tumor to the total liver volume is >= 70% (if the liver function is basically normal, a small amount of iodized oil emulsion and granular embolization agent may be considered for fractional embolization); 5. For peripheral blood leukocytes and platelets significantly reduced, leukocytes 450 ms, female > 470 ms, the QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Less than 4 weeks from the last clinical trial; 12. Known to be abused by psychotropic substances and unable to quit or mental disorders; 13. The researchers think inappropriate.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); Disease Control Rate (DCR);Overal Survival (OS);Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactFeng Weijian
Shijiazhuang Ping'an Hospital
Outcome results
None listed