Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:HAIC treatment every 3 weeks for up to 6 treatments
Adebrelimab, 20 mg/kg, IV, D1, Q3W, in combination with bevacizumab, 15 mg/kg, IV, Q3W
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily enrolled in this study by signing an informed consent form; 2.Aged 18-75 years (inclusive of 18 and 75) (calculated on the date of signing the informed consent), both male and female; 3.Patients with hepatocellular carcinoma confirmed by imaging CT/MRI; 4. BCLC C and not suitable for surgery, or progressed after surgery and/or local treatment; abdominal nuclear magnetic enhancement or abdominal CT enhancement confirming combined portal cancer embolization Vp 3, or Vp 4); 5.For patients who have progressed after local therapy, local therapy (including, but not limited to, surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) has been completed at least 4 weeks prior to the baseline imaging scan, and toxic reactions (other than alopecia) resulting from the local therapy must have been recovered to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 ( NCI-CTCAE v5.0) rating = 12 weeks; 11. The function of major organs is basically normal, and severe blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency diseases meet the requirements of the program: Routine blood tests: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor [G-CSF], no corrective therapy within 7 days) Hemoglobin > = 90 g/L; Neutrophil count > = 1.5×109/L; Platelet count >=50×109/L; Biochemical tests: (no albumin transfusion within 14 days) serum albumin > = 29 g/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 mL/min (Cockcroft-Gault formula below) Male: Cr clearance = ((140-age) × weight) / (72× blood Cr) Female: Cr clearance = ((140-age)× weight)/(72× blood Cr) × 0.85 Weight unit: kg; Blood Cr unit: mg/mL; Urine protein < 2+ (if urine protein is = 2+, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification <1.0 g can be enrolled); Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) < = 1.5× ULN (for anticoagulant therapy at stable doses such as low molecular weight heparin or warfarin, and INR is within the expected therapeutic range of anticoagulants, screening can be made); Thyroid-stimulating hormone (TSH) < = ULN; T3 and T4 levels should be examined if abnormalities occur, and normal T3 and T4 levels can be selected; Cardiac ultrasound: left ventricular ejection fraction (LVEF) greater than or equal to 60%. 12. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be < 2×103 IU/mL and willing to receive antiviral therapy throughout the study period (treatment according to local standard treatment, such as entecavir), and the doctor will judge whether it is eligible for enrollment according to the patient's individual conditio
Exclusion criteria
Exclusion criteria: 1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Active malignancy other than HCC within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., can be enrolled; 2. Patients who are ready to undergo or have previously received organ or allogeneic bone marrow transplantation; 3. Received other investigational drug treatment within 28 days prior to initiation of study treatment; 4. Clinically symptomatic moderate or severe ascites, i.e., those who require therapeutic puncture and drainage or a Child-Pugh score of >2 (except for those who only show a small amount of ascites on imaging but are not accompanied by clinical symptoms); Uncontrolled or moderate or above pleural effusion, pericardial effusion; 5. History of gastrointestinal bleeding or definite gastrointestinal bleeding tendency within 6 months before the start of study treatment, such as: bleeding risk or severe esophageal and gastric varices, locally active peptic ulcer lesions, and persistent fecal occult blood are not eligible for enrollment (if fecal occult blood is positive in the baseline period, it can be retested, and if it is still positive after reexamination, gastroduodenoscopy (EGD) is required, and esophageal and gastric varices with bleeding risk indicated by EGD cannot be enrolled); 6. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment; 7. Known hereditary or acquired bleeding (e.g., coagulation dysfunction) or thrombotic tendency, such as hemophilia patients; Current or recent (within 10 days prior to the start of study treatment) prior to the use of full-dose oral or injectable anticoagulant drugs or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin, low molecular weight heparin is allowed); 8. Current use or recent prior use (within 10 days prior to initiation of study treatment) aspirin (> 325mg/day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazole; 9. Thrombosis or embolic events within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.; 10. Have uncontrolled cardiac clinical symptoms or diseases, such as: Cardiac insufficiency or cardiac color ultrasound examination according to New York Heart Association (NYHA) criteria above grade II: LVEF (left ventricular ejection fraction) 450ms (males); QTc > 470ms (female) (QTc interval calculated by Fridericia's formula; If the QTc is abnormal, it can be tested three times continuously at an interval of 2 minutes, and the average value can be taken); 11. Patients with hypertension that are not well controlled with antihypertensive medication (systolic blood pressure > = 140 mmHg or diastolic blood pressure > = 90 mmHg) (based on > = average of BP readings obtained from 2 measurements), allowing the above parameters to be achieved through the use of antihypertensive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Disease Control Rate;Time to Progression;Duration of Response;Adverse Events; | — |
Countries
China
Contacts
Public ContactZhenyu Zhu
the Fifth Medical Center of Chinese PLA General Hospital
Outcome results
None listed