Clinical trial · Interventional
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
NCT03592706CI-TRIAL-00044702unknownPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in： 1. Reduction of tumor size 2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
Conditions
Conditions (2)
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 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IKC (Immune Killer Cells) | Biological | — | UNRESOLVED |
| TACE (Transcatheter Arterial Chemoembolization) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IKC and TACE
- description
- IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)
- interventionNames
- Biological: IKC (Immune Killer Cells)
- Procedure: TACE (Transcatheter Arterial Chemoembolization)
- type
- ACTIVE_COMPARATOR
- label
- TACE
- description
- TACE (Transcatheter Arterial Chemoembolization)
- interventionNames
- Procedure: TACE (Transcatheter Arterial Chemoembolization)
Primary outcomes (2)
- measure
- Change of tumor size
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign and give written informed consent. 2. Age≧20 years, but\<80 years. 3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations. 4. Barcelona staging system stage B and C. 5. Never receive TACE treatment and comply with the standard of TACE treatment. 6. Child-Pugh stage A and B. 7. ECOG performance status 0 to 2. Exclusion Criteria: 1. Participant of other clinical trial within the past 4 weeks of screening period. 2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period. 3. Carriers of HIV or HTLV within the past 4 weeks of screening period. 4. With Active acute or chronic infection by (investigator's judgement). 5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example: 5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction. 5.2 With previous history of encephalopathy within the past six months. 5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis). 6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
References
Publications (0)
Data not yet available
No reference posted for this study.