Clinical trial · Interventional
Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT04162158CI-TRIAL-00041639unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic NK cells combined with targeted drug in the treatment for advanced HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic NK cells therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Targeted drug combined with allogeneic NK cell treatment group
- description
- In addition to traditional symptomatic supportive treatment, Sorafenib, regolfinib or levabinib will be administered in combination with allogeneic NK cells (3 cycles).
- interventionNames
- Biological: allogeneic NK cells therapy
- type
- NO_INTERVENTION
- label
- Targeted drug treatment group
- description
- Sorafenib, regolfinib or levabinib will be administered in addition to traditional symptomatic supportive care.
Primary outcomes (2)
- measure
- Incidence of Adverse Events
- timeFrame
- From the date of enrollment to the end of two years of follow-up.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase); * Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points; * Laboratory criteria: 1. Liver function: Child A/B, ALT \< 200 U/L, AST \< 200 U/L, Tbil \<51μmol/L 2. Renal function: Creatinine clearance ≥ 60ml/minute 3. Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB\>80 g/L 4. Cardiac function: No abnormality in cardiac enzyme and ECG * Survival expectation is greater than 6 months; * Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs. * The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form; Exclusion Criteria: * Women who are pregnant or breast-feeding. * Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases. * Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days. * Patients with other serious systemic and psychiatric diseases. * Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration. * Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
References
Publications (1)
- DERIVEDUong TNT, Yoon M, Chung IJ, Nam TK, Ahn SJ, Jeong JU, Song JY, Kim YH, Nguyen HPQ, Cho D, Chu TH, Dang GC, Nguyen NPNM. Direct Tumor Irradiation Potentiates Adoptive NK Cell Targeting Against Parental and Stemlike Cancer in Human Liver Cancer Models. Int J Radiat Oncol Biol Phys. 2024 May 1;119(1):234-250. doi: 10.1016/j.ijrobp.2023.11.023. Epub 2023 Nov 21. PMID 37981041