hepatocellular carcinoma
Conditions
Interventions
treatment group:Icariin Soft Capsules, sintilimab and bevacizumab
control group:sintilimab and bevacizumab
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients need to meet all the following criteria to be enrolled in this study: 1) Able to provide informed consent and willing to sign an approved informed consent form; 2) Age = 18 years old, regardless of gender; 3) HCC patients who meet the clinical diagnostic criteria of the National Health Commission's "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition), and/or have been confirmed through pathological tissue/cytological examination; Allow ablation and TACE treatment history before the combination of icariin and Xindilimab with bevacizumab treatment; 4) The Chinese liver cancer staging (CNLC) is stage IIb-IIIb; 5) Child Pugh score: A level or better B level (= 7 points); 6) At least one measurable lesion (according to the mRECIST 1.1 standard, the spiral CT scan length diameter of the measurable lesion is = 10mm or the short diameter of the malignant lymph node is = 15mm); 7) ECOG PS score: 0-2 points; 8) Expected survival time = 3 months; 9) The main organ functions meet the following standards: ? Hematopoietic function indicators: Platelets = 75 × 109/L, hemoglobin = 8.5 g/L, white blood cells = 3.0 × 109/L; ? Liver function indicators: total bilirubin = 1.5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 × ULN; Albumin = 28 g/L; ? Renal function indicators: serum creatinine = 1.5 × ULN, or creatinine clearance rate = 50 mL/min; 10) If HBV-DNA = 104 copies/mL (2000IU/mL), antiviral liver protection treatment must be given first, and HBV-DNA<104 copies/mL (2000IU/mL) can be enrolled in the group; And continue to take antiviral drugs, monitor liver function and hepatitis B virus load; 11) Female subjects of childbearing age must undergo a serum/urine pregnancy test within 7 days prior to the start of the study medication, and the result is negative. They must agree to use reliable and effective contraceptive methods during the trial and within 120 days after the last trial medication administration. Male subjects of childbearing age must agree to use reliable and effective contraceptive methods during the trial period and within 120 days after the last trial administration; 12) Not participating in other clinical trials within 4 weeks prior to screening; If other trials fail to screen cases or participate in other non-interventional clinical studies (such as epidemiological studies), those who meet the requirements of this trial can be enrolled.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible for inclusion in this study 1) Known hepatobiliary cell carcinoma, mixed cell carcinoma, and fibrous lamellar cell carcinoma; Previously (within 5 years) or simultaneously suffering from other incurable malignant tumors, excluding cured skin basal cell carcinoma and cervical carcinoma in situ; 2) Patients with a history of esophageal and gastric variceal bleeding or abdominal infection; 3) Have experienced liver encephalopathy and/or liver kidney disease within 6 months prior to signing the informed consent form; 4) Positive for human immunodeficiency virus (HIV) antibodies; 5) Inability to swallow, chronic diarrhea or intestinal obstruction, significantly affecting medication administration and absorption; 6) Suffering from myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and/or cardiac dysfunction in the New York Heart Association (NYHA) standards of III to IV, as per the National Cancer Institute Adverse Event Terminology Standard (NCI CTCAE v5.0) level II or above; 7) Active autoimmune diseases requiring systemic treatment (such as NSAIDs, immunosuppressants, biological agents, corticosteroids, etc.), except for autoimmune diseases receiving alternative treatment (such as hypothyroidism receiving thyroxine treatment, type 1 diabetes receiving insulin treatment, adrenal or pituitary insufficiency receiving physiological corticosteroids, etc.); 8) Known to have central nervous system metastasis, those suspected of having central nervous system metastasis need to undergo head MRI examination to rule it out; 9) Significant abnormalities in coagulation function: International standardized ratio (INR)>1.5 or prothrombin time (PT)>16 seconds; 10) Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures; 11) Have a history of schizophrenia or abuse of psychotropic substances; 12) Known to be allergic or intolerant to icariin soft capsules, Xindiliximab, bevacizumab, and excipients; 13) The researcher believes that other situations are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival ;progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progress;objective response rate ;disease control rate ;quality of life;safety; | — |
Countries
China
Contacts
Public ContactWanxu ying
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed