Liver transplantation for liver cancer
Conditions
Interventions
Intervention group:The study predefines four dose groups: 25 µg, 50 µg, 100 µg, and 150 µg, with dose escalation conducted using a "3+3" design.In the "3+3" design, 3 participants are enrolled in each
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >=18 years. 2. Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC). 3. Patients who are assessed by the investigator as having liver transplantation indications and who are willing to undergo liver transplantation, and who, after evaluation, require bridging therapy or downstaging therapy during the liver transplantation waiting period. 4. Peripheral blood positive for hepatitis B surface antigen (HBsAg), regardless of whether peripheral blood HBV DNA is positive. 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0–1. 6. Life expectancy >=3 months. 7. Good major organ function, with relevant test results meeting the following criteria: Hemoglobin >=80 g/L, neutrophil count >=1.5×10^9/L, platelet count >=50×10^9/L (no use of granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, recombinant human erythropoietin, or recombinant human thrombopoietin within 7 days before the first dose, or within 5 half-lives of the drug (whichever is shorter); no blood component transfusion within 7 days before the first dose); Total bilirubin =50 mL/min (Cockcroft-Gault formula); Prothrombin time (PT), international normalized ratio (INR) <=1.5× ULN (unless on warfarin anticoagulation); If the investigator believes that any of the above parameters are below the protocol's lower limit due to the progression of liver cancer and related liver diseases, this can be discussed with the sponsor and CRO medical team to determine whether to include the patient. 8. Female participants of childbearing potential must not be pregnant during the study period and must agree to voluntarily use effective contraception during the study and for 4 months after treatment cessation. Pregnant test results for women of childbearing potential must be negative. 9. Able to understand and voluntarily sign a written informed consent form before participating in the trial. 10. Able to communicate effectively with the investigator and comply with the protocol to complete the study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of other malignancies, except for those with a history of cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, gastrointestinal mucosal carcinoma, or other malignancies that the investigator considers eligible for inclusion and have not relapsed within 5 years prior to screening. 2. Patients with a history of or currently suffering from hepatic encephalopathy; patients with known untreated or poorly controlled central nervous system metastases. 3. Patients currently experiencing clinically significant ascites that require intervention or treatment to control. 4. Known history of or currently present heart disease with uncontrolled clinical symptoms, such as: New York Heart Association (NYHA) class II or higher heart failure, unstable angina, myocardial infarction within the last 6 months, clinically significant and requiring treatment or intervention supraventricular or ventricular arrhythmias. 5. Any active autoimmune disease or a history of autoimmune diseases, including but not limited to immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathies, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel diseases including Crohn’s disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (except for type I diabetes controlled with a stable dose of insulin). 6. A history of thrombotic events (arterial or venous) within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 7. Clinical signs or symptoms of bowel obstruction and/or gastrointestinal obstruction within 1 month prior to enrollment, including incomplete obstruction related to underlying disease, or requiring treatment for complete bowel obstruction/obstructive syndrome/obstruction symptoms; except for patients who have undergone definitive (surgical) treatment to alleviate symptoms. 8. Any bleeding event, including: Any severe bleeding event graded >=2 within 4 weeks prior to enrollment; Imaging showing tumor invasion of major blood vessels or the investigator judging that the tumor has a very high likelihood of invading major blood vessels during treatment, causing fatal hemorrhage; A history of gastrointestinal bleeding within 6 months prior to enrollment, or clear gastrointestinal bleeding or bleeding events due to esophageal and/or gastric varices, without having received preventive treatment such as endoscopic intervention or TIPS; Known hereditary or acquired bleeding or thrombophilia (e.g., hemophilia, coagulation disorders), or currently receiving thrombolytic therapy (except for routine low-dose anticoagulation or antiplatelet therapy). 9. A known history of interstitial pneumonia or highly suspected interstitial pneumonia; or patients with lung abnormalities that could interfere with the detection or management of suspected drug-related pulmonary toxicity during the study. 10. Known allergy to the investigational drug (including any excipients). A history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, localized allergic necroti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerated dose;Optimal biological dose;Safety before and after liver transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;disease control rate; | — |
Countries
China
Contacts
Public ContactJiayin Yang
West China Hospital, Sichuan University
Outcome results
None listed