Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Medication based on organoid drug sensitivity results
Control group:Medication based on clinical experience
Sponsors
The 910th Hospital of the PLA Joint Logistics Support Force
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. No gender restriction, age 18-70 years; 2. Diagnosis of primary liver cancer based on the diagnostic criteria of the Primary Liver Cancer Treatment Guidelines (2024 edition); 3. Patients with a single tumor less than 5 cm in diameter, preoperative predictions of MVI as high risk, and postoperative pathological confirmation of hepatocellular carcinoma with concurrent MVI; 4. Pathological results show: Microvascular invasion (M1, M2); 5. The subject or guardian understands and voluntarily signs the informed consent form, willing and able to fulfill the scheduled visits, treatment plan, laboratory tests, etc., as required by the protocol; 6. Expected survival exceeds 6 months; 7. Previously not received systemic drug treatment, local treatment, or traditional Chinese medicine for primary liver cancer; 8. No radiation therapy received in the 12 weeks prior to the first administration; 9. Liver function Child-Pugh grade A or a score of 7 in grade B; 10. ECOG score of 0-1; 11. Having adequate organ and bone marrow function, laboratory test values must meet the following requirements within 7 days prior to random grouping (it is not allowed to meet these conditions by administering any blood components, growth factors, albumin, or other corrective treatment medications within the 14 days prior to obtaining laboratory tests), specifically as follows: (1) Complete blood count: absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 75 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL; (2) Liver function: total bilirubin (TBIL) = 28 g/L; (3) Kidney function: serum creatinine (Cr) = 50 mL/min (Cockcroft-Gault formula); urinalysis results show urine protein = 2, a 24-hour urine collection should be conducted and 24-hour urine protein quantification < 1g; (4) Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN; 12. For female subjects of childbearing age, a urine or serum pregnancy test should be negative within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is ordered. And voluntarily use an appropriate contraceptive method during the observation period and within 8 weeks after the last dose of study drug; Women of non-childbearing age are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; For men, an adequate method of contraception should be used during the observation period and for 8 weeks after the last dose of study drug; If there is a risk of conception, all subjects (male and female) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Uncorrectable coagulopathy with significant bleeding tendency; 2. Exceptions for target diseases: evidence of any coexisting malignant disease; 3. Diagnosis of other malignant diseases within 3 years prior to the first dose (excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ); 4. Patients requiring long-term anticoagulation or antiplatelet therapy who cannot discontinue medication; 5. Patients with hepatic encephalopathy or resistant pleural or abdominal effusion requiring treatment; 6. Other antitumor treatments or systemic therapies: treatment with a defined antitumor traditional Chinese medicine within 2 weeks, or treatment with traditional Chinese medicine or immunomodulatory agents with antitumor indications (including thymosin, interferons, interleukin, except for local use to manage pleural effusion); 7. Systemic therapy: Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before administration. Alternative therapies (such as thyroid hormones, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment. Patients receiving systemic glucocorticoid treatment within 7 days prior to the first dose (excluding nasal, inhaled, or other topical glucocorticoids) or any other form of immunosuppressive therapy are allowed to use physiological doses of glucocorticoids (= 2; myocardial infarction within 6 months prior to randomization; recent hemorrhage due to esophageal or gastric varices within the last 6 months; poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); a history of non-infectious pneumonia requiring glucocorticoid treatment within one year prior to the first administration, or current clinically active interstitial lung disease; active tuberculosis; the presence of active or uncontrolled infections requiring systemic treatment; clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; patients with unstable or active ulcers, gastrointestinal bleeding; poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L); urinalysis indicating proteinuria >=, and confirmed 24-hour urinary protein quantification >1.0 g; uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium ion or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate treatment; long-term untreated wounds or fractures; patients with mental disorders who are unable to cooperate with the treatment; 10. Lactating or pregnant female subjects; 11. Patients whom the investigator assesses to be unable or unwilling to comply with the requireme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Adverse drug reactions; | — |
Countries
China
Contacts
Public ContactRunze Shang
The 910th Hospital of the PLA Joint Logistics Support Force
Outcome results
None listed