Clinical Trials /

Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection

NCT03575806

Description:

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 randomized 1:1 either to the experimental arm to receive autologous Tcm cells immunotherapy and TACE or to the no intervention arm (TACE alone).

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection
  • Official Title: A Study of Combining Trans Arterial Chemoembolization (TACE) and Autologous Tcm Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma (HCC) With Microvascular Invasion (MVI) After Radical Resection

Clinical Trial IDs

  • ORG STUDY ID: CancerIHCAMS-HCC-Tcm
  • NCT ID: NCT03575806

Conditions

  • Hepatocellular Carcinoma
  • Malignant Neoplasm

Purpose

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 randomized 1:1 either to the experimental arm to receive autologous Tcm cells immunotherapy and TACE or to the no intervention arm (TACE alone).

Detailed Description

      Hepatocellular carcinoma (HCC) is one of the common cancer worldwide, which is the third
      cause of cancer related deaths. Radical hepatic resection remains the main treatment for
      hepatocellular carcinoma, the 5-year survival rate of HCC after surgery was 60-70%.
      Unfortunately, HCC is prone to postoperative recurrence that more than 50% of patients
      relapse within 2 years, which has become the key to restrict the therapeutic effect of
      hepatocellular carcinoma. Microvascular invasion (MVI) is one of the main risk factors for
      poor prognosis in HCC.

      Autologous cell immunotherapy is to collect patient's own immune cells and then given back to
      the patient after amplified in vitro that can improve the anti-tumor immune response. Tcm
      (central memory T cells) are effective anti-tumor immune cells that exhibit the long-term
      survival and self-renewal capacity in vivo. Autologous Tcm immunotherapy combining
      chemotherapy, surgery or radiotherapy would effectively prolong survival period, prevent
      tumor recurrence and metastasis, then improve quality of life in patients.
    

Trial Arms

NameTypeDescriptionInterventions
TACE+Tcm groupExperimentalExperimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.
    TACE groupActive ComparatorActive comparator: TACE to treat HCC.

      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. Alpha fetoprotein (AFP) < 400 ng/ml.
      
               10. Subjects must meet the indications for autologous Tcm cells immunotherapy.
      
              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).
      
                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. patients 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.
            
      Maximum Eligible Age:75 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Disease-free Survival (DFS) treatment with a combination of TACE and Tcm immunotherapy
      Time Frame:24 months
      Safety Issue:
      Description:To evaluate the clinical efficacy and safety of autologous Tcm immunotherapy for HCC with MVI after radical resection according to Disease-free survival (DFS)

      Secondary Outcome Measures

      Measure:Overall Survival (OS) with a combination of TACE and Tcm immunotherapy
      Time Frame:24 months
      Safety Issue:
      Description:Assess overall survival of autologous Tcm immunotherapy in HCC patients with MVI after radical resection

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Cancer Institute and Hospital, Chinese Academy of Medical Sciences

      Last Updated