Hepatocellular Carcinoma
Conditions
Interventions
monotherapy:IPM001 injection
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who understand and voluntarily sign the informed consent forms; 2. Subjects aged 18–75 years old (inclusive), male or female; 3. Subjects with progressive hepatocellular carcinoma who failed second-line therapy; 4. Subjects with an expected survival >= 6 months; 5. Subjects with a Child-Pugh score 50 kg, female > 45 kg; 11. Subjects with liver tumor lesions that can be used for tumor tissue biopsy. If feasible, the subjects must agree to provide tumor tissue specimens at baseline; 12. Subjects with no major organ dysfunctions (by laboratory test): (1) white blood cell count >= 3.0*10^9/L; (2) neutrophil count >= 1.5*10^9/L; (3) hemoglobin >= 90 g/L; (4) platelet count >= 30*10^9/L; (5) total bilirubin = 3.0 g/dL (30 g/L); (8) blood creatinine <= 1.5*ULN; (9) generally normal bleeding and coagulation time, with PT prolongation <= 4 s; (10) no serious cardiopulmonary diseases; 13. For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the following conditions are eligible to be enrolled: (1) HBV-HCC: resolved HBV infection (specified as with positive HBV surface antibody and HBV core antibody, negative HBV surface antigen, and the HBV-DNA below the lower limit of detection); chronic HBV infection (specified as with positive HBV surface antigen or the HBV-DNA above the lower limit of detection, as well as the HBV-DNA less than 10^6 copies/mL), with concomitant antiviral therapy. (2) HCV-HCC: resolved or active HCV infection (specified as with positive HCV antibody or the HCV-RNA above the lower limit of detection, as well as the HCV-RNA less than 10^3 copies/mL), where concomitant antiviral therapy may be given for active HCV infection. 14. Subjects with no obvious genetic diseases; 15. Subjects who have not received any live attenuated vaccines within 4 weeks prior to the first administration; 16. Subjects who are able to follow the clinical study protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with immunodeficiency or a history of autoimmune disorders (e.g., rheumatoid arthropathy, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes mellitus, etc.); 2. Subjects with severe concurrent medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, serious infection and infectious disease, active peptic ulcer, presence of active hemorrhage, and severe organ failure; 3. Subjects with myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Grade III or IV cardiac failure defined by the New York Heart Association (NYHA), epileptic seizure, and mechanical or paralytic ileus within 6 months prior to the first administration of the investigational drug; 4. Subjects who have received chemotherapy and hormonal therapy within 28 days prior to signing the informed consent forms, or are currently taking other investigational drugs; 5. Subjects with lymphoma, leukemia, myelodysplastic syndrome (MDS), or myelosuppression; 6. Subjects with allergy or a history of hypersensitivity to human blood albumin, or a history of allergy or hypersensitivity to any investigational drug or its excipients; 7. Subjects with chronic diseases requiring immunotherapy or hormonal therapy; and subjects currently receiving corticosteroids for other diseases (except those using topical or inhaled steroids); 8. Pregnant or lactating women; 9. Subjects with mental or neurological disorders that are not easily controlled; 10. Subjects infected with human immunodeficiency virus (commonly known as AIDS) or treponema pallidum (commonly known as syphilis); 11. Subjects with a history of other malignant tumors within the last 5 years; 12. Subjects with prior allogeneic stem cell transplantation or solid organ transplant; 13. Subjects with a history of drug or alcohol abuse; 14. Subjects with any irAE of >= Grade 3 following prior immunotherapy; 15. Subjects who, in the judgment of the investigator, are not suitable to participate in this clinical study (e.g., with poor compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and Tolerability;Progression-Free-Survival;Overall Survival;CTL levels and clonal typing in Peripheral blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Overall Survival;CTL levels and clonal typing in Peripheral blood;safety;The relationship between CTL cells or safety related factors and therapeutic efficacy; | — |
Countries
China
Contacts
Public ContactZhao Haitao
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed