advanced Hepatocellular Carcinoma
Conditions
Interventions
Group 1 :PM8002 combined with PM1016
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, ECOG score 0-1; 2. HCC confirmed by pathology or clinical diagnosis, BCLC stage B/C, Child-Pugh liver function score = 3 months; 5. Sufficient organ function; 6. At least one measurable lesion (based on mRECIST) assessed by the investigator to meet the injection volume requirements; 7. Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Containing fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components confirmed by pathology; 2. Uncontrollable systemic diseases such as: hypertension, diabetes, history of heart disease, etc.; 3. There is tumor thrombus in main portal vein, inferior vena cava, or combined with other tumors; 4. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion; 5. Evidence of significant coagulation disorders or other significant bleeding risks; 6. Anti-tumor treatment for the research disease within 4 weeks before the start of the study; 7. Unstable immune system or infectious diseases; 8. HIV-infected persons; 9. Patients with history of stem cell transplantation and organ transplantation; 10. History of severe allergic diseases, history of severe drug allergy, or known allergy to any drug or drug component of this study drug; 11. There are liver disease-related complications that need treatment: uncontrollable pleural effusion, pericardial effusion, ascites, etc.; 12. Known history of alcohol abuse, psychotropic substance abuse or drug abuse; 13. People with mental disorders or poor compliance; 14. Pregnant or lactating women; 15. According to the investigator's judgment, the subject's basic condition may increase the risk of receiving the study drug treatment, or cause confusion for the explanation of the toxic reaction and AE; 16. Other investigators consider it inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Treatment related adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progress free survial;Overall survival;Duration of Response;Time to progress;Anti-drug antibody;Pharmacokinetic characteristic; | — |
Countries
China
Contacts
Public ContactJia Fan
Pumis Biotechnology (Zhuhai) Co., Ltd.
Outcome results
None listed