Clinical trial · Interventional
Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Radical Resection
A Multicenter, Randomized, Open-label Phase II Study of Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Preventing Recurrence in Patients With Primary Hepatocellular Carcinoma (HCC) at High Recurrence Risk After Radical Resection
NCT05213637CI-TRIAL-00056353unknownPhase 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 multi-center, randomized, open-label pivotal phase II study to evaluate the efficacy and safety of EAL as adjuvant therapy in preventing recurrence in patients with primary HCC at high recurrence risk after radical resection.
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded Activated Lymphocytes (EAL) | Biological | — | UNRESOLVED |
| transarterial chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EAL Treatment Group
- description
- The patients with primary HCC will receive 12\~20 doses of EAL infusion (1×10\^9\~2×10\^10 cells per dose) in combination of a single transarterial chemoembolization (TACE) after radical resection.
- interventionNames
- Biological: Expanded Activated Lymphocytes (EAL)
- Procedure: transarterial chemoembolization (TACE)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- The patients with primary HCC will receive a single TACE after radical resection.
- interventionNames
- Procedure: transarterial chemoembolization (TACE)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Stage Ia\~IIIa primary HCC with high recurrence risk (defined as single tumor ≥5cm in diameter, or single tumor \<5cm in diameter with MVI, PVTT, hepatic vein invasion, satellite lesions or AFP ≥400ng/mL, or multiple tumors). 2. Patients who have undergone a radical resection. 3. ECOG PS Score 0\~2. 4. Child-Pugh Score ≤ 7. 5. Patients with adequate hematologic and end-organ function. 6. HBV-HCC and HCV-HCC patients with active viral infection may receive antiviral treatment simultaneously. 7. Patients who have a life expectancy of at least 6 months. Exclusion Criteria: 1. Patients with a history of immune deficiency or autoimmune diseases (such as rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes mellitus, etc.). 2. Patients with a history of other malignant tumors in the past 5 years. 3. Patients who received chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, and hormone therapy within 1 month prior to screening. 4. Patients who have received microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local ablation methods for liver tumors. 5. Patients with postoperative organ dysfunction or heart and lung diseases. 6. Patients allergic to albumin or with serious allergy history or mental disease. 7. Pregnant or lactating women. 8. Anticipated other clinical trials within 4 weeks before this trial. 9. Patients with HIV or Treponema pallidum infection, septicemia and other uncontrolled infection. 10. Patients after organ or bone marrow transplant. 11. Patients with drug or alcohol abuse/addiction. 12. Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
References
Publications (0)
Data not yet available
No reference posted for this study.