advanced hepatocellular carcinoma
Conditions
Interventions
Patients with advanced second-line hepatocellular carcinoma:VItamin K2 treatment in combination with immune checkpoint inhibitor
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histopathologically confirmed advanced hepatocellular carcinoma who have failed multiple lines of therapy and for whom there are no standard treatment options. 2. Age = 18 years. 3. ECOG PS score of 0 or 1 or 2. 4. Progresses after treatment and no standard treatment regimen is recommended. 5. At least one measurable lesion according to RECIST version 1.1 criteria. 6. Adequate organ function, as defined below: 1) Liver function: serum total bilirubin (TBIL) = 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 x ULN. (2) Renal function: urine protein <2+ or 24h urine protein quantification <1g and creatinine clearance (Ccr) =60 mL/min. (calculated using the Cockcroft/Gault formula): Female: Ccr= (140 - years) x weight (kg) x 0.85 /72 x serum creatinine (mg/dL) Males: Ccr= (140 - years) x weight (kg) x 1.00 /72x serum creatinine (mg/dL) Note: For patients =65 years of age, or for patients with normal serum creatinine but creatinine clearance <60 mL/min according to the Cockcroft/Gault formula, the Standard 24-Hour Urinary Residual Calculation can be used to calculate creatinine clearance. The formula for the standard 24-hour urine retention method is: creatinine clearance = urine creatinine concentration (mmol/L) × urine volume per minute (mL/min) ÷ plasma creatinine concentration (µmol/L). For the same patient, the same formula should be used for creatinine clearance calculations during the Screening Period of this study and during treatment with study drug. 3) Adequate coagulation function, defined as International Normalized Ratio (INR) =1.5 or Prothrombin time (PT) =1.5 times ULN; if the patient is receiving anticoagulation, as long as the coagulation function is within the range of the anticoagulant formulation. 7. Expected survival = 12 weeks. Female patients of childbearing potential or male patients whose sexual partner is a female of childbearing potential are required to use effective contraception throughout the treatment period and for 180 days after the last administration of the test drug (see Section 4.3). 8. sign a written informed consent form and be able to comply with protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe cirrhosis. 2. patients at high risk of hemorrhage or perforation due to significant tumor invasion of the aorta or trachea, or patients who have developed a fistula. 3. concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study. 4. have received palliative treatment for a localized lesion within 2 weeks prior to the first dose. 5. have received systemic systemic therapy with herbal or immunomodulatory agents with antitumor indications (including thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose of study drug. 6. the presence of toxicity (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antineoplastic therapy that did not recover to National Cancer Institute Common Terminology for Adverse Events Version 5.0 (NCI CTCAEv5.0) Grade 1 prior to the first dose of study treatment. 7. known active tuberculosis. 8. known presence of HIV infection (HIV antibody positive). 9. active or clinically poorly controlled serious infections. 10. 10. symptomatic congestive heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled cardiac arrhythmia. 11. significant malnutrition, as defined by the New York Heart Association class II-IV, or as defined by the New York Heart Association class II-IV. 11. significant malnutrition, such as the need for intravenous supplemental nutritional support therapy lasting > 7 days; except when malnutrition is corrected intravenously for more than 4 weeks prior to the first dose of study treatment 12. uncontrolled metabolic disorders or other non-malignant neoplastic organ or systemic diseases or secondary reactions to cancer that could result in higher medical risk and/or uncertainty in the evaluation of survival 13. history of other primary malignant tumor, except for ? Malignancies that have been in complete remission for at least 2 years prior to enrollment and for which no other treatment was required during the study period; ? Adequately treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease recurrence; ? Adequately treated carcinoma in situ without evidence of disease recurrence; ? Prostate cancer under close surveillance. 14. female patients who are pregnant or breastfeeding. 15. other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory test values that may result in the following outcomes 15. other acute or chronic medical conditions, psychiatric illnesses, or abnormal laboratory test values that could result in an increased risk associated with study participation or administration of study medication, or interfere with the interpretation of study results, and, in the investigator's judgment, classify the patient as ineligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| alpha fetoprotein (AFP); | — |
Secondary
| Measure | Time frame |
|---|---|
| PG-SHA scale; | — |
Countries
China
Contacts
Public ContactWenshengqiu
The Affiliated Hospital of Qingdao University
Outcome results
None listed