None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Prior to dosing of the IP, HAIC with 5-fluorouracil (5-FU) and cisplatin will be administered in 2 cycles and then subjects to be treated with Vax-NK/HCC will be
Sponsors
Vaxcell-Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 19 years diagnosed with HCC 2. Child-Pugh class A (Points 5 to 6) or upper-class B (Point 7) 3. Patients with advanced HCC that is unresectable or refractory to local hepatic treatment and showing SD, PR, or CR in mRECIST assessment after 2 cycles of HAIC ?HAIC is indicated for: ? Patients who were refractory to two transcatheter arterial chemoembolizations (TACEs) within 6 months ? Patients who failed or cannot use first- and second-line systemic treatments such as sorafenib, lenvatinib, regorafenib, nivolumab, cabozantinib, ramucirumab, atezolizumab and bevacizumab; or ? Patients with portal vein involvement 4. Patients meeting the following: ? Absolute neutrophil count (ANC) = 1,000/µL, platelets (PLTs) = 50,000/µL, hemoglobin (Hb) = 9 g/dL ? Serum aspartate transaminase (AST) and alanine transaminase (ALT) = 5 × upper limit of normal (ULN), serum creatinine = 1.5 × ULN ?? International normalized ratio (INR) < 1.7 5. Ability to perform daily activities (patients with the Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1) 6. Written consent provided by the patient or the patient’s legally acceptable representative for study participation
Exclusion criteria
Exclusion criteria: 1. Had chemotherapy, radiotherapy, immunotherapy (monoclonal antibody, cytokine therapy, etc.), hormonal therapy, local tumor treatment, or target therapy within 4 weeks of screening 2. Extrahepatic metastasis 3. Child-Pugh lower class B or C 4. Curable with local treatment 5. Had liver transplantation 6. Difficult to perform daily activities (ECOG performance status of = 2) 7. Had immune cell therapy within 6 months prior to screening 8. Had other malignant tumor that were diagnosed within last 5 years or are currently being treated 9. Hypersensitivity to 5-FU and cisplatin 10. Endoscopically confirmed venous or untreated ulcer with a risk of bleeding, or bleeding of grade =3 using the National Cancer Institute (NCI)-common terminology criteria for adverse events (CTCAE ver5.0) were observed within 4 weeks prior to screening 11. Severe or uncontrolled cardiovascular disease 12. Active infection such as sepsis 13. Pregnant or breast-feeding women, or women of childbearing potential who are not using appropriate contraceptive methods 14. Accompanied by autoimmune disease 15. Determined to be ineligible to participate in the clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator assessed Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator assessed Objective response rate (ORR);Disease control rate (DCR);Time to progression (TTP);Overall survival (OS);quality of life (QoL, EORTC QLQ-C30) | — |
Countries
Korea, Republic of
Contacts
Public Contactjin-a koh
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed