Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Icaritin soft capsule + Cinobutanin tablets Placebo
Control group:Icaritin soft capsule placebo + Cinobutalin tablets
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >= 18 years old; 2. HCC patients who strictly meet the clinical diagnostic criteria of the Chinese Diagnosis and Treatment Guideline of primary liver cancer (2022 edition) , and/or who with diagnosis confirmed histopathologically/cytologically; 3. Unresectable HCC patients; 4. Patients with a peripheral blood composite biomarker score >= 2 points, i.e., two or three of the following requirements are met: (1) AFP >= 400 ng/mL (1 point); (2) TNF-a = 7.0 pg/mL (1 point); 5. No prior first-line systemic treatment for HCC, including sorafenib, lenvatinib, donafenib, atezolizumab plus bevacizumab, sintilimab plus a bevacizumab biosimilar, camrelizumab plus apatinib, and durvalumab plus tremelimumab, oxaliplatin-based systemic chemotherapy (FOLFOX4), icaritin, huachansu, and other anti-cancer drugs such as targeted agents, immune checkpoint inhibitors, and systemic chemotherapy; 6. Child-Pugh score = 40 x 10^9/L, hemoglobin >= 80 g/L, white blood cell >= 2.0 x 10^9/L; (2) Liver function: total bilirubin = 28 g/L; (3) Renal function: Serum Creatinine = 50 mL/min; 8. If HBV-DNA >= 10^4 copies/mL (2000 IU/mL), antiviral drug with liver protection therapy must be initiated before enrollment, until HBV-DNA decreases to = 75 years; 2) HBV-DNA >= 500 IU/mL and = 40 x 10^9/L; 4) Hemoglobin Level = 80 g/L; 5) White Blood Cell Count = 2.0 x 10^9/L; 6) Urine Protein >= 1+; 7) Hypertension which is not well controlled by antihypertensive drugs (systolic blood pressure >= 140 and = 90 and = 50% but < 70% ; 10) Tumor invasion of the main trunk of the portal vein and tumor thrombus occupancy < 50%; 11) Tumor inv
Exclusion criteria
Exclusion criteria: 1. Tumor occupancy >= 70% of liver, or tumor thrombus occupancy >= 50% of the main trunk of portal vein, or mesenteric vein or inferior vena cava tumor thrombus; 2. Moderate-to-severe ascites, i.e., the score of the indicator is > 2; Moderate-to-severe, or symptomatic pleural effusion and pericardial effusion requiring drainage procedures; 3. Receipt of major surgery (craniotomy, thoracotomy, laparotomy, hip replacement, etc.) within 28 days prior to randomization or planned to receive major surgery during the study; 4. Other types of primary liver cancer, such as intrahepatic cholangiocarcinoma, mixed HCC and cholangiocarcinoma, fibrolamellar HCC, etc. Other malignancies within 5 years prior to signing the informed consent form or at present, excluding radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin and/or radically resected carcinoma in situ; 5. Pregnant or lactating women; 6. Grade 2 or above myocardial ischemia or myocardial infarction (NCI-CTCAE v5.0), poorly-controlled arrhythmia, and/or New York Heart Association (NYHA) class III or IV cardiac insufficiency; 7. Patients who previously received allogeneic transplantation including liver transplantation, or plan to undergo liver transplantation during the study; 8. History of hepatic encephalopathy and/or hepatic nephropathy within 6 months prior to signing the informed consent form; 9. HCV-RNA positive, ALT and/or AST > 2 x ULN; 10. Human immunodeficiency virus (HIV) antibody positive; 11. Severe infection (>= Grade 3 of NCI-CTCAE v5.0 criteria) at randomization; 12. Unable to swallow, chronic diarrhea or intestinal obstruction, which will significantly affect oral administration and absorption of the study drug; 13. History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, or with clear tendency for gastrointestinal hemorrhage at present, such as local active ulcers, stool occult blood >= 2+ or positive at two consecutive tests (attention should be paid to exclude the influence of food, drugs and other diseases); 14. Active autoimmune diseases requiring systemic treatment (e.g., NSAIDs, immunosuppressants, biologics, corticosteroids, etc.) with the exception of those receiving replacement therapy (e.g., hypothyroidism treated with thyroxine, type 1 diabetes mellitus treated with insulin, adrenal or pituitary insufficiency treated with physiologic corticosteroids, etc.); 15. Known central nervous system (CNS) metastasis; patients suspected of CNS metastasis need to undergo cerebral MRI/CT for exclusion; 16. Significant coagulation function abnormalities: international standardized ratio (INR) > 1.5 or prothrombin time (PT) > 16 s; 17. History of schizophrenia or psychiatric drug abuse; 18. Known allergy or intolerance to any ingredients in Icaritin or Huachansu preparations; 19. Other conditions that the investigator considers inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 9/12/18-month Overall Survival rate;time to progression;progression free survival;objective remission rate;Disease control rate;Time to deterioration of quality of life; | — |
Countries
China
Contacts
Public ContactHao Jihui
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed