atural Killer (NK) Cell Therapy Combined with Hepatic Artery Infusion Chemotherapy (HAIC) in Patients with Advanced Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0004642
• Lead Sponsor: Vaxcell-Bio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-09-14
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator assessed Objective response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Investigator assessed Objective response rate (ORR);Disease control rate (DCR);Time to progression (TTP);Overall survival (OS);quality of life (QoL, EORTC QLQ-C30)