Hepatocellular carcinoma
Conditions
Interventions
Treatment group:hepatic artery catheterization and infusion of 5% sodium bicarbonate injection
Sponsors
The Second Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Patients who are in strict compliance with the clinical diagnostic criteria of the ''Guidelines for the Diagnosis and Treatment of Primary Liver Cancer'' (2019 edition) or patients with IIb to IIIb diagnosed by histopathological or cytological examinations; 3. At least one measurable intrahepatic lesion; 4. Child-Pugh liver function rating: grade A or better grade B (= 24 weeks; 8. The function of major organs is normal, that is, the following criteria are met: (1) Routine blood examination: HB >= 90 g/L, ANC >= 1.5 x 10^9/L, PLT >= 80 x 10^9/L; (2) Biochemical tests: ALB >= 29 g/L, ALT and AST < 5ULN, TBIL <= 1.5 ULN, creatinine <= 1.5 ULN (Only one of the two indicators of albumin and bilirubin in the Child-Pugh scale is 2 points); (3) Thyroid function test is within the normal range; 9. Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 10. The patients voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. There are contraindications to anti-PD-1 monoclonal antibody therapy; 2. Known hepatic cholangiocarcinoma; past (within 5 years) or other uncured malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Patients who are about to undergo organ transplantation or who have undergone organ transplantation in the past; 4. Ascites with clinical symptoms, that is, the need for therapeutic paracentesis or drainage, or Child-Pugh score > 2; 5. Patients with hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 6. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >=450 ms for men and >=470 ms for women); previous symptomatic ischemic or hemorrhagic cerebrovascular disease ; 7. There are many factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs); 8. Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency to gastrointestinal bleeding, such as esophageal varices with bleeding risk, locally active ulcer lesions, and fecal occult blood >= (++) are not eligible for inclusion; gastroscopy is required if fecal occult blood (+); 9. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study; 10. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 11. Patients with CNS metastases or known brain metastases; 12. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 13. Urine routine shows urine protein >=++ or confirmed 24-hour urine protein quantification >1.0 g; 14. Severe thyroid disease that cannot be controlled by treatment; 15. Rheumatism or autoimmune disease, receiving immunosuppressant or high-dose hormone therapy after organ transplantation; 16. Lactating patients; 17. Have a history of mental illness or abuse of psychotropic substances; 18. Patients who have developed bone metastases have received palliative radiotherapy within 4 weeks before participating in the study (radiation area > 5% bone marrow area); 19. Patients with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver-enhanced MRI lesion necrosis; | — |
Countries
China
Contacts
Public ContactChao Ming
Outcome results
None listed