Primary liver cancer
Conditions
Interventions
Experimental group:Multiple administration
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Patients with diagnosed hepatocellular carcinoma; 3. Patients should be failed in standard therapy, tolerance or unwilling to receive standard therapy; 4. Barcelona Clinic Liver Cancer (BCLC) stage C or Stage B ; 5. According to RECIST1.1 criteria, at least one target lesion can be measured. It could be considered as a target lesion which previously treated with radiotherapy or local area treatment must have imaging evidence of disease progression; 6. The organ function level must meet the following requirements: it has appropriate organ and hematopoietic function, and no serious abnormal heart, lung, liver and kidney function and immune deficiency are confirmed according to the following laboratory examination and auxiliary examination; (1) Absolute neutrophil (NE) >= 1.5 x 10^9 /L; (2) Platelets (PLT) >= 75 x 10^9 /L; (3) Hemoglobin (HGB) >= 90 g/L; (4) Albumin (ALB) >= 28 g/L; (5) Serum total bilirubin (TBIL) = 3 months; 9. Use of effective contraception from the time of signing the informed consent until 3 months after the last dose measures; 10. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Past or present patients with significant clotting or hemorrhagic diseases, such as thrombotic diseases or hemophilia; 2. Patients who received anticoagulant or thrombolysis therapy within 4 weeks prior to treatment initiation (except for patients who received low doses of anticoagulant therapy as determined by the investigator, including ordinary heparin 470ms in women and > 450 ms in men during the screening period; (4) Symptomatic coronary heart disease requiring medical treatment; (5) Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg); 6. HBsAg positive and HBV DNA>=2000 IU/mL; 7. Anti-hcv positive with HCV RNA > 100 IU/mL; 8. Human immunodeficiency virus (HIV) infected (anti-HIV positive); 9. Difficulty in resting breathing or the need for oxygen support due to advanced malignancies or other diseases (e.g., heart failure, chronic obstructive pulmonary disease, pulmonary edema, etc.); 10. Patients who had received first - or second-line drug therapy for liver cancer within 4 weeks before participating in the trial (e.g., Donafenib, Lunavatinib, sorafenib, Regofenib, Apatinib, PD-1/PD-L1 monoclonal antibody, etc.); 11. Received Chinese patent medicine, Chinese herbal medicine or Chinese herbal decoction for liver cancer (such as Acoradine, Epimedium, etc.) within 2 weeks before participating in the experiment; 12. Patients suffering from malignant tumors other than liver cancer; 13. Patients who have received major surgery or trauma within the last 4 weeks and have not fully recovered; 14. Toxic reactions (e.g., leukocytes/platelets/anaemia/bleeding) after previous anticancer treatment have not returned to grade 0 or 1 (except hair loss); 15. Previous recipients of liver transplantation; 16. Attended other clinical investigators within 4 weeks prior to the start of the trial; 17. Allergic constitution, known to be allergic to test drug ingredients; 18. A history of drug abuse (drug abuse (substance abuse) refers to the repeated and extensive use of a drug (or substance) with dependent properties for non-medical purposes, the development of dependence on such drugs (addiction) by the user, and the compulsive and unending pursuit of the particular psychoactive effects of the drug); 19. Alcohol addicts; 20. Pregnant or lactating patients; 21. The presence of any other co-existing medical conditions, such as uncontrolled lung disease, severe infection, mental disorder, severe uncontrolled diabetes, connective tissue disease, or bone marrow suppression, that the investigator believes may interfere with the study or evaluation, or the presence of pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose for multiple administration;Response evaluation criteria in solid tumors;Dose-limiting toxicity;Pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactWang Fusheng
Outcome results
None listed