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

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ClinicalTrials.gov Identifier: NCT03575806
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Newish Technology (Beijing) Co., Ltd.
Information provided by (Responsible Party):
Hong Zhao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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 cells immunotherapy and TACE or to the no intervention arm (TACE alone).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Malignant Neoplasm Combination Product: TACE plus autologous Tcm immunotherapy Procedure: TACE Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: TACE+Tcm group
Experimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.
Combination Product: TACE plus autologous Tcm immunotherapy

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.


Active Comparator: TACE group
Active comparator: TACE to treat HCC.
Procedure: TACE
TACE:transcatheter arterial chemoembolization.




Primary Outcome Measures :
  1. Disease-free Survival (DFS) treatment with a combination of TACE and Tcm immunotherapy [ Time Frame: 24 months ]
    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 :
  1. Overall Survival (OS) with a combination of TACE and Tcm immunotherapy [ Time Frame: 24 months ]
    Assess overall survival of autologous Tcm immunotherapy in HCC patients with MVI after radical resection



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575806


Contacts
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Contact: Hong Zhao (010)87787100

Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Hong Zhao    (010)87787100      
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Newish Technology (Beijing) Co., Ltd.
Investigators
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Study Director: Hong Zhao Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Hong Zhao, assistant director physician, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03575806     History of Changes
Other Study ID Numbers: CancerIHCAMS-HCC-Tcm
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Chlorotrianisene
Immunologic Factors
Physiological Effects of Drugs
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents