HBV-HCC
Conditions
Interventions
Western medicine treatment group:Immune checkpoint inhibitor therapy
Integrated traditional Chinese and Western medicine treatment group:Yangyin Fuzheng Jiedu decoction combined with immune checkpoint inhibitor therapy
Sponsors
Beijing Ditan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Older than 18 years old regardless of gender in line with the diagnostic criteria for primary liver cancer in the guidelines for the diagnosis and treatment of primary liver cancer officially revised by the National Health Commission of the People'sRepublic ofChina in 2024; 2) History of chronic hepatitis B HBsAg positive > 6 months; 3) ECoG physical status score 0-1; 4) Have not received any systematic treatment for HCC in the past; 5) Barcelona Clinic Liver Cancer stage (BCLC stage) is stage C or stage B that is not suitable for surgery and / or local treatment; 6) Child Pugh liver function rating: Grade A and good grade B (= 7 points) and no history of hepatic encephalopathy; 7) According to the response evaluation criteria for solid tumors (RECIST version 1.1) at least one measurable lesion can also be selected as the target lesion if there is clear disease progression for the lesion that has received local treatment in the past; 8) The expected survival is more than 3 months; 9) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Complicated with other hepatotropic virus infection or alcoholic liver autoimmune liver primary biliary cirrhosis hereditary metabolic liver disease and previous liver transplantation; 2) Within 4 weeks before the first study drug treatment he had received liver surgery and / or local treatment for HCC except palliative radiotherapy for bone metastatic lesions to reduce pain; 3) Subjects who did not recover from any toxicity and / or complications of local treatment (including interventional therapy radiofrequency therapy etc.) previous chemotherapy surgery and radiotherapy that is subjects who did not fall to grade = 1 (ncictcae version 5.0) (excluding hair loss and fatigue); 4) Received anti-tumor drug treatment within 2 weeks before the first study drug treatment (including but not limited to traditional Chinese medicine preparations with anti-tumor indications); 5) Moderate or severe ascites or ascites requiring drainage or pleural effusion or pericardial effusion requiring drainage and / or accompanied by tachypnea symptoms within 4 weeks before the first study drug treatment; 6) With known active central nervous system metastasis (CNS) and / or cancerous meningitis; 7) Suffering from other malignant tumors (except cured cervical carcinoma in situ non melanoma skin cancer or other tumors / cancers that have undergone radical treatment and have no signs of disease for at least 5 years); 8) Have bleeding tendency high bleeding risk or coagulation dysfunction; 9) There was evidence of portal hypertension and the investigator assessed that the risk of bleeding was high; 10) There was a history of gastrointestinal perforation and / or fistula abdominal abscess intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition) extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea) Crohn's disease ulcerative colitis or long-term chronic diarrhea within 6 months before the first study drug treatment; 11) Active known or suspected autoimmune disease history of infection with human immunodeficiency virus (HIV test positive) or other acquired or congenital immunodeficiency diseases; 12) Accompanied by serious medical diseases; 13) Pregnant and lactating women; 14) Those with serious mental illness; 15) Patients with incomplete clinical data and relevant examination results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Immunological index;Kamofsky Activity Status Rating;Quality of life score;TCM syndrome score;Complete remission rate; | — |
Countries
China
Contacts
Public ContactYangzhiyun
Beijing Ditan Hospital Affiliated to Capital Medical University
Outcome results
None listed