Primary hepatocellular carcinoma
Conditions
Interventions
CT102 Group:single-dose CT102
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Over 18 years old, male or female; 2. Diagnosed advanced liver cancer; 3. Barcelona clinic liver cancer (BCLC) stage B-C; 4. Subjects with no standard therapy; 5. Must have measurable disease as defined by at least one target lesion by RECIST v1.1 criteria, the lesions received radiotherapy or local treatment must have imaging evidence of disease progression before being regarded as target lesions. 6. The organ function must meet the following requirements: adequate organ and hematopoietic function, no serious heart, lung, liver, and kidney function abnormalities and immune deficiency as confirmed by the following laboratory examinations and auxiliary examinations; Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet (PLT) >=75x10^9 /L; Hemoglobin (HGB) >=90 g/L; Total bilirubin (TBIL) =3 months; 9. Subjects of child-bearing age must agree to use adequate contraception; 10. Willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Known important coagulation or bleeding disorders in the past or present, such as thrombosis or hemophilia; 2. Received anticoagulation or thrombolytic therapy =180mmHg and/or diastolic blood pressure >=110mmHg upon screening evaluation); 7. Subjects who have difficulty breathing or need oxygen therapy due to advanced malignant tumors or other diseases; 8. Received first-line or second-line treatment for liver cancer <=4 weeks prior to initiating protocol therapy; 9. Known additional malignant tumor; 10. Known HIV infection; 11. Major surgery or trauma without a full recovery <=4 weeks prior to initiating protocol therapy; 12. Subjects who have not recovered (i.e., <=grade 1) from toxic reactions (such as white blood cell/platelet/anemia/hemorrhage, etc., except for hair loss) due to previous anti-tumor therapy; 13. Known history of liver transplantation; 14. Has participated in other clinical trials <=4 weeks prior to initiating protocol therapy; 15. Known allergic constitution, or allergic to the components of the test drug; 16. Known history of alcohol or drug abuse; 17. Women who are pregnant or lactating; 18. Subjects who are fertile but unable or unwilling to use medically accepted adequate contraception during the trial period and within 6 weeks after the end of the trial; 19. Known other comorbidities that may interfere with the trial or evaluation, such as uncontrolled lung disease, severe infection, active peptic ulcer, mental disorder, severe uncontrolled diabetes, connective tissue disease, or bone marrow suppression, etc., or participating in the trial may lead to greater risk, as judged by the investigator; 20. Subjects that cannot comply with the requirements of the clinical trial protocol, with poor compliance, and have trouble completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerance, dose-Limiting toxicity, maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| measurement of tumor; | — |
Countries
China
Contacts
Public ContactDeling Zhu
Hangzhou Tianlong Pharmaceutical Co., Ltd.
Outcome results
None listed