This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment. The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).
PBMCs of enrolled patients were collected and then further separated by density gradient centrifugation. After washing three times, the cells were resuspended in serum-free medium with recombinant human IL-2 and α-GalCer. Restimulation with α-GalCer-pulsed autologous DCs was done on days 7. After 14 days of cultivation, the iNKT cells were harvested, washed thrice, and then resuspended in saline. The frequency of iNKT cells before and after cultured in vitro were determined by flow cytometry analysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The patients received different doses of in vitro-expanded autologous iNKT cells through intravenous infusion. The dosage was escalated from 3x10\^7 cells/m2 to 6x10\^7 cells/m2 to 9x10\^7 cells/m2. The maximum tolerated dose (MTD) was defined as the last dose level, and the dosage would be up to 1x10\^10 cells/m2 if no MTD was observed after a 3+3 design.
IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Number of Adverse Events
Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Time frame: During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
Progression-Free Survival (PFS)
PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard. Progression is defined as a ≥25% increase in the nadir of the sum of target lesions.
Time frame: Through study completion, an average of 12 months.
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
Disease stabilization (SD) or progressive diseasee (PD) were valuated by imaging according to the irRC standard. Complete response (CR): Disappearance of all lesions; Partial response (PR): ≥50% decrease from baseline; SD: Neither CR or PD is met; PD≥25% increase in the nadir of the sum of target lesions.
Time frame: 4 weeks, 8 weeks, 12 weeks and 24 weeks after cell infusion.
Overall Survival (OS)
OS is the time that passes from the date that patient enrolled in the clinical trial and the date on which the patient dies, according to the irRC standard.
Time frame: Through study completion, up to 20 months.
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