Liver cancer
Conditions
Interventions
Group of liver cancer :Patients with advanced liver cancer received Simvastatin 20mg po qn, Orlistat 120mg po tid, Trimetazidine 20mg po tid combined with second-line treatment drugs for advanced live
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Advanced liver cancer patients with histopathologically confirmed multi-line therapy failure and no standard treatment regimen. 2. Age =18 years old. 3. The ECOG PS score is 0 or 1 or 2 points. 4. Progress after treatment, and no standard treatment plan is recommended. 5. At least one measurable lesion according to Recist version 1.1 standards. 6. Having adequate organ function, as defined below: 1) Liver function: serum total bilirubin (TBIL) =1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5×ULN. 2) Renal function: urinary protein < 2+ or 24h urinary protein quantity < 1g and creatinine clearance (Ccr) =60 mL/min (calculated using Cockcroft/Gault formula) : Women: Ccr= (140-age) x Body weight (kg) x 0.85/72 x serum creatinine (mg/dL) Male: Ccr= (140-age) x Body weight (kg) x 1.00/72x serum creatinine (mg/dL) Note: For patients =65 years of age, or those with normal serum creatinine but whose creatinine clearance is < 60 mL/min as calculated by the Cockcroft/Gault formula, a standard 24-hour urine retention method may be used to calculate creatinine clearance. Standard 24-hour urination method calculation formula: creatinine clearance = urinary 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 to calculate creatinine clearance during the screening period of this study and during treatment with the study drug. 3) Full thrombin function, defined as International Normalized Ratio (INR) =1.5 or Prothrombin time (PT) =1.5 ULN. If the patient is receiving anticoagulant therapy, as long as the coagulation function is within the range of the anticoagulant drug formulation. 7. Expected survival =12 weeks. Female patients of childbearing age or male patients with a sexual partner of a female of childbearing age are required to use effective contraception for the entire treatment period and 180 days after the last trial drug administration (see section 4.3). 8. Sign a written informed consent and be able to comply with the visit and related procedures required by the program.
Exclusion criteria
Exclusion criteria: 1. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis. 2. Patients who are at high risk of bleeding or perforation due to significant tumor invasion of the aorta or trachea, or who have developed fistulas. 3. Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study. 4. Received palliative treatment for local lesions within 2 weeks before the first dose. 5. Systemic systemic treatment with Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) was received within 2 weeks before the first administration. 6. Toxicity (excluding alopecia, non-clinically significant, and asymptomatic laboratory abnormalities) that did not return to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAEv5.0) level 1 from prior antitumor therapy prior to the first dose of study therapy. 7. Known to have active tuberculosis. 8. There is a known HIV infection (HIV antibody positive). 9. Severe infections that are active or poorly controlled clinically. 10. Symptomatic congestive heart failure (New York Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmias. 11. Significant malnutrition, such as the need for intravenous nutritional support treatment for > 7 days; Malnutrition was not corrected by intravenous injection for more than 4 weeks prior to the first dose of study therapy. 12. Uncontrolled metabolic disorders or other non-malignant organ or systemic disease or cancer secondary reactions and may lead to higher medical risk and/or uncertainty in the evaluation of survival. 13. History of other primary malignancies, except: Complete remission of malignant tumors for at least 2 years prior to enrollment and no other treatment required during the study period; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence; Prostate cancer under close monitoring. 14. Pregnant or nursing female patients. 15. Other acute or chronic diseases, mental disorders or laboratory test values that may cause the following results Often: increases the risk associated with study participation or study drug administration, or interferes with the interpretation of study results, and classifies patients as ineligible to participate in the study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Progression Free Survival(PFS);Disease Control Rate(DCR);Duration of Response(DoR); | — |
Countries
China
Contacts
Public ContactWensheng Qiu
Affiliated Hospital of Qingdao University
Outcome results
None listed