hepatocellular carcinoma
Conditions
Interventions
treatment group:Addition of paricalcitol to the existing treatment regimen
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. No restrictions on gender, age 18-75 years; 2. Serum vitamin D level = 1.5 × 10^9/L; Platelet count (PLT) >= 75 × 10^9/L; Hemoglobin (HGB) >= 9.0 g/dL; (2) Liver function: Serum total bilirubin (TBIL) = 28 g/L; (3) Renal function: Serum creatinine (Cr) = 50 mL/min (calculated by Cockcroft-Gault formula); Urinalysis shows urine protein = 2+, a 24-hour urine collection must demonstrate 24-hour urine protein < 1 g; (4) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN; 13. For female subjects of childbearing potential, a negative urine or serum pregnancy test must be confirmed within 3 days prior to the first dose of the study drug (Cycle 1, Day 1). If the urine pregnancy test result is inconclusive, a blood pregnancy test is required. Additionally, they must voluntarily use appropriate contraception methods during the observation period and for 8 weeks after the last dose of the study drug. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. For male subjects, appropriate contraception methods must be used during the observation period and for 8 weeks after the last dose of the study drug; 14. If there is a risk of pregnancy, all subjects (regardless of gender) must use contraception with a failure rate of <1% per year throughout the treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Uncorrectable coagulation dysfunction with evident bleeding tendency; 2. Exceptions related to the target disease: mixed hepatocellular carcinoma and cholangiocarcinoma; 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 of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); 4. Patients requiring long-term anticoagulation or antiplatelet therapy that cannot be discontinued; 5. Patients with hepatic encephalopathy or refractory pleural effusion/ascites requiring treatment; 6. Other antitumor or systemic therapies: treatment with Chinese patent medicines with clear antitumor effects within 2 weeks; use of Chinese patent medicines with antitumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for controlling pleural effusion) within 2 weeks; 7.Systemic therapy: active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to administration. Replacement therapy (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; systemic glucocorticoid therapy (excluding nasal sprays, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose. Physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent) are permitted; 8. Severe hepatic or renal insufficiency; 9. Presence of any severe or uncontrolled systemic diseases, such as: resting electrocardiogram showing significant and symptomatic abnormalities in rhythm, conduction, or morphology that are difficult to control, including complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation; unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class >= 2; myocardial infarction within 6 months prior to randomization; esophageal or gastric variceal bleeding within the last 6 months; poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease; active tuberculosis; active or uncontrolled infection requiring systemic treatment; clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; patients with unstable or active ulcers or gastrointestinal bleeding; poorly controlled diabetes (fasting blood glucose > 10 mmol/L); urinalysis showing urine protein >= ++ and confirmed 24-hour urine protein > 1.0 g; uncontrolled hypercalcemia (ionized calcium > 1.5 mmol/L, total calcium > 12 mg/dL, or corrected serum calcium above ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; long-term unhealed wounds or fractures; patients with psychiatric disorders unable to cooperate with treatment; 10. Serum vitamin D level >= 30 ng/mL; 11. Female subjects who are breastfeeding or pregnant; 12. Patients deemed by the investigator as unable or unwilling to comply with the requirements of the study protoco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Median effective time; | — |
Countries
China
Contacts
Public ContactShengxian Yuan
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed