Clinical trial · Interventional
Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection
A Single-center, Open-label, Exploratory Trial of Autologous Immunotherapy for Hepatocellular Carcinoma (HCC) With Microvascular Invasion (MVI) After Radical Resection
NCT03575806CI-TRIAL-00045489completedPhase 2Results postedClinicalTrials.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 assess the efficacy and safety of combining autologous Tcm immunotherapy and TACE in HCC patients with MVI after radical resection. Patients will be assigned either to the experimental arm to receive autologous Tcm immunotherapy and TACE or to the active comparator (TACE alone).
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 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| TACE plus autologous Tcm immunotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE+Tcm group
- description
- Experimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.
- interventionNames
- Combination Product: TACE plus autologous Tcm immunotherapy
- type
- ACTIVE_COMPARATOR
- label
- TACE group
- description
- Active comparator: TACE to treat HCC.
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- Recurrence-free Survival (RFS) Time
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Be willing and able to provide written informed consent for the study.
2. Subject has accepted radical hepatic resection, and preoperative imaging is no vascular invasion.
3. Postoperative pathology confirmed Hepatocellular carcinoma with negative margin and microvascular invasion (MVI).
4. Age between 18-75 years old.
5. Radiology confirmed complete response (CR) after radical surgery.
6. Child-Pugh A.
7. Eastern Cooperative Oncology Group(ECOG) body condition score 0.
8. Adequate hepatic and renal function:
Hemoglobin ≥ 9.0g/dl. Absolute neutrophil count (ANC) \> 1,500/mm3. Platelets ≥ 50,000/ul. Total bilirubin (TBIL) ≤ 2mg/dl. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 the upper limit of normal (ULN) for the institution.
Alkaline phosphatase (ALP) ≤ 4 the upper limit of ULN. Prothrombin time (PT) \> 50% or prothrombin time-international normalized ratio (PT-INR) \< 2.3.
Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN.
9. Female subjects have had a negative blood pregnancy test within 2 week,
10. Subjects be willing to use appropriate contraception during the trial and 2 weeks after the last administration of immunotherapy.
11. Radiology such as CT and MRI were performed in 4 weeks before the study.
Exclusion Criteria:
1. Recurrent HCC.
2. Portal vein embolus.
3. Cardiovascular disease:
Evidence of NYHA functional class III or IV heart disease. Unstable coronary artery disease (CAD) is not allowed, while Myocardial Infarction (MI) 6 months of starting study is allowed.
Cardiac arrhythmias requiring antiarrhythmic drugs except β-blockers or digoxin are not allowed.
Uncontrolled hypertension.
4. History of Human Immunodeficiency Virus (HIV) or syphilis infection.
5. Severe inflammation, NCI CTCAE Version 3.0 grade \> 2.
6. Epilepsy requiring steroid or antiepileptic drugs.
7. History of allotransplantation.
8. History or any evidence of hemorrhage.
9. Subjects undergoing renal dialysis.
10. Pregnancy or breast-feeding.
11. Prior or undergoing cancers that primary sites are different from the carcinoma of this study. Exceptions to this are:
Cervical carcinoma in situ (CIS) Cured basal cell carcinoma Superficial bladder tumor Cured cancers over 3 years before the study
12. Uncontrolled Ascites by diuretic treatment.
13. History of encephalopathy.
14. Gastrointestinal hemorrhage in 30 days before the study.
15. History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
16. Major surgery except radical hepatic resection was performed in 4 weeks before the study.
17. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
18. Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
19. Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial.
20. Any condition that would interfere with or endanger the safety and compliance of subjects.References
Publications (1)
- DERIVEDCai J, Zhao J, Liu D, Xie H, Qi H, Ma J, Sun Z, Zhao H. Efficacy and Safety of Central Memory T Cells Combined With Adjuvant Therapy to Prevent Recurrence of Hepatocellular Carcinoma With Microvascular Invasion: A Pilot Study. Front Oncol. 2021 Dec 3;11:781029. doi: 10.3389/fonc.2021.781029. eCollection 2021. PMID 34926296