Primary liver cancer
Conditions
Interventions
Trial Group:Detoxification formula+Lenvatinib+PD-1 inhibitor
Control group:Lenvatinib+PD-1 inhibitor
Sponsors
Department of Traditional Chinese Medicine Oncology First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old gender not limited; (2) Patients with primary liver cancer diagnosed by histopathological or cytological examination in accordance with the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2024 edition) and with at least one measurable lesion (according to RECIST 1.1 requirements the length of the measurable lesion on spiral CT scan should be = 10mm or the length of enlarged lymph nodes should be = 15mm); (3) BCLC stage B or C that cannot be surgically resected; Or CNLC stage IIb IIIa or IIIb that cannot be surgically resected; (4) I have not received any systemic treatment for primary hepatocellular carcinoma in the past including systemic chemotherapy targeted therapy immunotherapy biological therapy and combination therapy; Patients who receive adjuvant therapy after radical resection of liver cancer must meet the condition of recurrence at least 6 months after the end of treatment and have not received systematic treatment during the screening period; (5) Child Pugh liver function rating: A grade or good B grade (= 7 points); (6) Expected survival time at enrollment is greater than 3 months; (7) Within one week prior to enrollment the performance score of the Eastern Cancer Collaboration Group (ECOG) was 0-1 points; (8) Female patients of childbearing age or male patients with sexual partners of childbearing age must take effective contraceptive measures throughout the entire treatment period and 90 days after the last medication; (9) Before screening and preprocessing (baseline) subjects should meet the following test results. If there are laboratory test abnormalities that do not meet the following criteria re examination is allowed within one week. If the criteria are still not met the screening is considered a failure: a. Blood routine (should not have received supportive treatment such as blood transfusion platelet transfusion or cell growth factor (excluding recombinant erythropoietin) within 7 days prior to testing): Absolute neutrophil count (ANC) = 1.5 × 109/L; White blood cell count (WBC) = 2.5 × 109/L; Platelet count (PLT) = 75 × 109/L; Hemoglobin (Hb) = 8.5g/dL; b. Blood biochemistry: serum albumin (Alb) = 28g/L; Endogenous creatinine clearance rate = 50mL/min (using Cockcroft Gault formula); Alanine aminotransferase (ALT) aspartate aminotransferase (AST) alkaline phosphatase = 5 x upper limit of normal (ULN); Total bilirubin = 2 × ULN; c. Coagulation function international standardized ratio (IN R) = 2.3 d. Pancreatic function defined as amylase and lipase = 1.5 × ULN (10) Able to understand and sign informed consent forms willing and able to comply with all aspects of the agreement.
Exclusion criteria
Exclusion criteria: (1) The imaging manifestations of liver cancer correspond to any of the following: a) HCC with = 50% liver mass; b) Clearly invading the bile duct; c) Portal vein invasion of the main portal vein branch (VP4); (2) Participate in other clinical trials or use other investigational drugs within 4 weeks prior to the first treatment; (3) Received any anti-cancer treatment (including surgery percutaneous ethanol injection radiofrequency ablation transarterial chemoembolization hepatic artery chemotherapy biological immunotherapy hormone or radiation therapy) or any enhanced blood therapy (including blood transfusions blood products or drugs that stimulate blood cell production such as granulocyte colony-stimulating factor [G-CSF] etc.) within the 4 weeks prior to randomization; (4) Significant cardiovascular damage: History of congestive heart failure greater than New York Heart Association (NYHA) Class II unstable angina first dose of study drug within 6 months after myocardial infarction or stroke or arrhythmia requiring treatment during screening; (5) Extend QTc interval to>480ms; (6) Researchers believe that the subjects have poor gastrointestinal absorption or any other conditions that may affect the absorption of the detoxification formula; (7) Bleeding or thrombotic diseases or the use of anticoagulant drugs such as warfarin or similar drugs requiring INR monitoring (low molecular weight heparin treatment is allowed); (8) Occurrence of gastrointestinal bleeding or active hemoptysis (at least 2.5ml teaspoon of bright red blood) within 28 days prior to randomization (9) Gastric or esophageal varices that require treatment; (10) Simultaneously having two or more active primary tumors of different types; (11) Subjects with urine protein>1+in routine urine tests will undergo 24-hour urine collection to quantitatively evaluate proteinuria. Subjects with urinary protein = 1g/24h will be disqualified; (12) Known intolerance to lenvatinib or PD-1 inhibitors or detoxifying granules (or any excipients); (13) Human immunodeficiency virus (HIV) positive or active infections requiring treatment (excluding hepatitis virus); (14) The subjects underwent liver transplantation; (15) The patient has any active known or suspected autoimmune disease including but not limited to: autoimmune hepatitis interstitial pneumonia enteritis vasculitis nephritis; Asthma in which subjects require bronchodilators for medical intervention; However the following patients are allowed to be included: vitiligo psoriasis alopecia without systemic treatment well controlled type I diabetes hypothyroidism with normal thyroid function after replacement treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;safety analysis;Quality of life score; | — |
Countries
China
Contacts
Public ContactZhai Xiaofeng
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed