Primary Hepatocellular Carcinoma
Conditions
Interventions
Control Group:Patients receive only lenvatinib. For patients with a body weight < 60 kg, the dose is 8 mg once daily
for patients with a body weight = 60 kg, the dose is 12 mg once daily.
Experimental Group:Sanshimao Traditional Chinese Medicine (TCM) Granules (each dose contains 30 g of Radix Actinidiae Valvatae [Maorénshen], 30 g of Herba Salviae Chinensis [Shíjiànchuan], 12 g of Pse
Sponsors
First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age: 18-75 years old, gender (no gender restriction); Diagnosed with unresectable hepatocellular carcinoma (HCC) based on the imaging techniques and/or biopsy guidelines in the Clinical Practice Guidelines for Primary Liver Cancer (2022 Version); At least 1 measurable target lesion according to the mRECIST criteria, meeting the following standards: Hepatic lesions: i) Lesions can be accurately measured in at least one dimension, =1.0 cm; ii) Lesions are suitable for repeated measurement; iii) Lesions show intratumoral arterial enhancement on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI); Extrahepatic lesions: i) Lymph node (LN) lesions: at least one dimension measured on the short axis =1.5 cm, excluding hilar LNs with a short-axis measurement =2.0 cm; ii) Nodular lesions with a maximum diameter =1.0 cm; Lesions previously treated with radiotherapy or local therapy must show radiological evidence of disease progression to be considered target lesions; Traditional Chinese Medicine (TCM) syndrome differentiation of blood stasis syndrome; BCLC staging of Stage B (TACE-ineligible) or Stage C; No prior systemic therapy before enrollment, including systemic chemotherapy (oxaliplatin-based chemotherapy), and/or targeted therapy (e.g., sorafenib, lenvatinib, etc.), and/or immunotherapy (e.g., pembrolizumab, camrelizumab, etc.); Child-Pugh classification of Grade A or B (=7 points); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1; Normal function of major organs (no correction therapy with blood components, cell growth factors, or albumin infusions administered within 14 days before obtaining laboratory tests), i.e., meeting the following criteria: (1) Routine blood test: Absolute Neutrophil Count (ANC) =1.5×10^9/L; Hemoglobin (Hb) =8.5 g/dL; Platelet count =75×10^9/L; (2) Liver function: Albumin =2.8 g/dL; Bilirubin =3.0 mg/dL; Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Alanine Aminotransferase (ALT) =2.5×Upper Limit of Normal (ULN); (3) Coagulation function: International Normalized Ratio (INR) =2.3; (4) Renal function: Creatinine clearance >30 mL/min calculated according to the Cockcroft-Gault formula; (5) Pancreatic function: Amylase and lipase =1.5×ULN; Blood pressure (BP) controlled with 0 or 1 type of antihypertensive drug; BP =150/90 mmHg at screening; no changes in antihypertensive drugs within 1 week before Cycle 1 or Day 1; Estimated survival time of more than 12 weeks before randomization; Male or female patients who are at least 18 years old at the time of signing the informed consent form (or any age above 18 years as determined by national legislation); Female patients must not be breastfeeding or pregnant at screening or baseline (confirmed by a negative ß-human chorionic gonadotropin [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG). If a negative screening pregnancy test is obtained more than 72 hours before the first dose of the study drug, a separate baseline assessment is required; Female patients of childbearing potential or male patients whose sexual partners are of childbearing potential must use effective contraceptive measures throughout the treatment period and within 90 days after the last dose; Provision of written informed consent and willingness and ability to comply with all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Imaging features of hepatocellular carcinoma (HCC) correspond to any of the following: (1) HCC occupying =50% of the liver; (2) confirmed invasion of the bile duct; (3) invasion of the main portal vein branches (VP4). 2. Patients must have received any anticancer treatment (including surgery, percutaneous ethanol injection, radiofrequency ablation, transarterial chemoembolization, intrahepatic chemotherapy, biological or immunotherapy, hormone therapy, or radiotherapy) or any blood enhancement therapy (including blood transfusion, blood products, or granulocyte colony-stimulating factor (G-CSF) or other hematopoietic-stimulating agents) within 28 days prior to enrollment. 3. For subjects who have not recovered from toxicity due to prior anticancer therapy, except for alopecia and infertility, recovery is classified as a Grade 2 or lower adverse event under the CTCAE5.0 criteria. 4. Significant cardiovascular impairment: History of congestive heart failure (NYHA class II or higher), unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of the investigational drug, or arrhythmia requiring treatment at screening 5. Prolong QTc interval to>480ms 6. In the investigator's opinion, gastrointestinal malabsorption or any other condition that may affect lenvatinib absorption, 7. Bleeding or thrombotic disorders, or use of anticoagulants such as warfarin or similar drugs requiring INR monitoring. (Low molecular weight heparin is permitted.) 8. Gastrointestinal bleeding or active hemoptysis (at least 0.5 teaspoon of bright red blood) within 28 days prior to enrollment 9. Gastric or esophageal varices requiring treatment 10. Within the past 36 months, active malignancies (excluding liver cancer or confirmed treatment of melanoma, basal or squamous cell carcinoma of the skin or cervical carcinoma in situ 11. Meningeal cancer 12. Any history of brain or subdural metastases 13. Participants with proteinuria>1+ in the urine dipstick test will undergo 24-hour urine collection for quantitative proteinuria assessment. Those with urinary protein =1g/24h will be excluded. 14. Arteriovenous shunt or arteriovenous fistula, correct diagnosis of tumor prevention 15. The investigator considers that the subject meets all medical or other criteria for exclusion from the clinical study 16. Known intolerance to lenvatinib or sorafenib (or any excipient) 17. Individuals requiring treatment for human immunodeficiency virus (HIV) positive or active infection (excluding hepatitis virus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Quality of Life Score;Safety Analysis;Plasminogen Activator Inhibitor-1;fibronectin;Liver Elasticity Ultrasound;Traditional Chinese Medicine Blood Stasis Score; | — |
Countries
CHINA
Contacts
Public ContactMeng Yongbin
First Affiliated Hospital of Naval Medical University
Outcome results
None listed