Hepatocellular carcinoma
Conditions
Interventions
Group 1:NaHCO2
Group 2:sphere
Sponsors
Tianjin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Initial patients with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology; 3. Palliative surgery or radiotherapy is not acceptable, and at least one of the largest tumors that can be measured is less than 15 cm; 4. Child-Pugh liver function rating A, B; 5. BCLC stage A, B, C; 6. ECOG PS score within 1 week before admission 0-1; 7. The life expectancy is more than 12 weeks; 8. Laboratory tests meet the following criteria: (1) Routine blood test: (14 days before screening, no blood transfusion, no G-CSF, no drug correction); HB > 90 g/L; ANC (>1.5*10^9/L); PLT > 60 *10^9/L; (2) Biochemical examination: (no ALB was transfused within 14 days) ALB > 29g/L; ALT and AST < 2.5*ULN; TBIL < 2*ULN; Creatinine < 1.5*ULN; 9. Women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days before admission, and the results are negative. They are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the test drugs. For men, they should be sterilized surgically or agree to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the drug; 10. Subjects planned to use the planned polyvinyl alcohol microspheres for treatment, volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatocellular carcinoma and diffuse hepatocellular carcinoma with central hepatic artery/hepatic vein fistula; patients with portal trunk metastasis and other distant metastases in BCLC-C stage; 2. Hepatobiliary and mixed cell carcinomas and fiberboard cell carcinomas are known; in the past (within 5 years) or with other incurable malignant tumors, except for cured skin basal cell carcinomas and cervical carcinoma in situ; 3. Patients preparing for liver transplantation (excluding those who have previously undergone liver transplantation); 4. Ascites with clinical symptoms requires therapeutic abdominal puncture or drainage; 5. Arrhythmias with grade II or above myocardial ischemia or myocardial infarction and poor control (including QTc interval (>450 MS for males and 1.5 or prothrombin time (PT) > ULN + 4 seconds), prone to bleeding or undergoing thrombolysis or anticoagulation therapy; 10. Patients with central nervous system metastasis or known brain metastasis; 11. Urinary routine showed that urinary protein (++) or confirmed 24-hour urinary protein quantification (>1.0 g); 12. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures; 13. Have a history of mental illness or psychotropic substance abuse; 14. Joint HIV infection patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Time to Progression, TTP;Objective response rate;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactHai-peng Yu
Tianjin Medical University Cancer Hospital
Outcome results
None listed