hepatocellular carcinoma
Conditions
Interventions
experimental group:Arterial injection of sodium bicarbonate injection combined with PD1 therapy
control group:Arterial injection of chemotherapy drug combined with PD1 therapy
Sponsors
the Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years old, male or female not limited; 2. Patients with IIIa to IIIb who strictly meet the clinical diagnostic criteria of the "Diagnosis and Treatment Standards for Primary Liver Cancer" (2022 edition) or have been diagnosed by histopathological or cytological examination; 3. At least one measurable intrahepatic lesion; 4. Child Pugh liver function rating: A grade or good B grade (= 7 points); 5. BCLC stage is C stage; 6. ECOG score within 1 week before enrollment: 0-1 point; 7. Expected survival period = 24 weeks; 8. The main organ functions are normal, which meets the following criteria: (1) Blood routine examination: a) HB=90 g/L; b) ANC=1.5×109/L; c) PLT=80×109/L; (2) Biochemical examination: a) ALB =30 g/L; b) ALT and AST<5 ULN; c) TBIL =1.5 ULN; d) Creatinine = 1.5 ULN; In the Child Pugh rating, only one of the two indicators, albumin and bilirubin, can score 2 points (3) Thyroid function test within normal range; 9. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, and they are willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug; 10. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
Exclusion criteria
Exclusion criteria: 1. There are contraindications for anti-PD-1 monoclonal antibody treatment; 2. Known hepatocellular carcinoma; Previously (within 5 years) or simultaneously with other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Patients who are preparing for organ transplantation or have undergone organ transplantation in the past; 4. Ascites with clinical symptoms that require therapeutic abdominal puncture or drainage, or a Child Pugh score greater than 2; 5. Patients with hypertension who cannot be reduced to the normal range through antihypertensive medication (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 males and = 470 ms for females); Previously experienced symptomatic ischemic or hemorrhagic cerebrovascular disease; 7. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect medication intake and absorption); 8. Individuals with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within the past 6 months, such as esophageal varices at risk of bleeding, locally active ulcer lesions, and fecal occult blood = (++), are not eligible for inclusion in the study; If there is occult blood in the stool (+), gastroscopy examination is required; 9. Within the 28 days prior to participating in this study, there has been an abdominal fistula, gastrointestinal perforation, or abdominal abscess; 10. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; 11. Patients who have already experienced central nervous system metastasis or known brain metastasis; 12. Patients with objective evidence of past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc; 13. Urine routine shows urine protein =++or confirms 24-hour urine protein quantification>1.0 g; 14. Severe thyroid diseases cannot be controlled through treatment; 15. Treatment with immunosuppressants or high-dose steroids for rheumatic or autoimmune diseases, or after organ transplantation; 16. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 17. Have a history of mental illness or abuse of psychotropic drugs; 18. Patients who have already experienced bone metastasis have received palliative radiotherapy (radiotherapy area>5% bone marrow area) within the 4 weeks prior to participating in the study; 19. Subjects with congenital or acquired immune dysfunction (such as HIV infected individuals), or active hepatitis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival,OS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progress,TTP;Progression Free Survival,PFS; | — |
Countries
China
Contacts
Public ContactMing Chao
the Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed