Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-free Survival (RFS) Time |
9.5; 12 | — |
| SECONDARY Overall Survival (OS) Rate at 24 Months |
25; 23; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written informed consent for the study.
- Subject has accepted radical hepatic resection, and preoperative imaging is no vascular invasion.
- Postoperative pathology confirmed Hepatocellular carcinoma with negative margin and microvascular invasion (MVI).
- Age between 18-75 years old.
- Radiology confirmed complete response (CR) after radical surgery.
- Child-Pugh A.
- Eastern Cooperative Oncology Group(ECOG) body condition score 0.
- 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.
- Epilepsy requiring steroid or antiepileptic drugs.
- History of allotransplantation.
- History or any evidence of hemorrhage.
- Subjects undergoing renal dialysis.
- Pregnancy or breast-feeding.
- 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
- Uncontrolled Ascites by diuretic treatment.
- History of encephalopathy.
- Gastrointestinal hemorrhage in 30 days before the study.
- History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
- Major surgery except radical hepatic resection was performed in 4 weeks before the study.
- Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
- Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
- Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial.
- Any condition that would interfere with or endanger the safety and compliance of subjects.
Data sourced from ClinicalTrials.gov (NCT03575806). 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. Informational only — not medical advice.