Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection
Condition: Hepatocellular Carcinoma; Malignant Neoplasm
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Neoplasms
Intervention: TACE plus autologous Tcm immunotherapy; TACE
Intervention description: TACE:transcatheter arterial chemoembolization.
Autologous Tcm immunotherapy: to collect patient's own immune cells and then given back to the patient after amplified in vitro.; TACE:transcatheter arterial chemoembolization.
Intervention MeSH terms: Chlorotrianisene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.