Phase 2
N=60
Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04011033 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Progression-Free Survival(PFS) — 5.7; 2.7 months — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- iNKT cells (Biological); Human recombinated Interleukin-2 (Drug); TAE/TACE (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beijing YouAn Hospital
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival(PFS) |
5.7; 2.7 | <0.001 sig |
| SECONDARY Overall Survival(OS) |
25.9; 17.3 | — |
| SECONDARY Objective Response Rate(ORR) |
14; 3 | =0.003 sig |
| SECONDARY Disease Control Rate (DCR) |
23; 9 | <0.001 sig |
| SECONDARY Adverse Events(AEs) |
0; 0; 0; 0; 3; 5 | — |
| SECONDARY Time to Quality of Life (QoL) Deterioration |
9.2; 3.0 | =0.001 sig |
Summary
Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE).
Eligibility Criteria
Inclusion Criteria
- Age 18-80 years.
- Patients with hepatocellular carcinoma (BCLC, stageB/C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
- Life expectancy of ≥ 12 weeks.
- WBC>3.0×10^9/L, LYMPH> 0.8×10^9/L, Hb>85g/L, PLT>50×10^9/L, Cre 10 cell/mL in peripheral blood mononuclear cell (PBMC).
- Able to understand and sign the informed consent.
Exclusion Criteria
- Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
- Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
- Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
- Unstable immune systematic diseases or infectious diseases;
- Combined with AIDS or syphilis;
- Patients with history of stem cell or organ transplantation;
- Patients with allergic history to related drugs and immunotherapy;
- Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
- Pregnant or lactating subjects;
- Unsuitable subjects considered by clinicians.
Data sourced from ClinicalTrials.gov (NCT04011033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.