A Single-center, Open-label, Exploratory Trial of Autologous Immunotherapy for Hepatocellular Carcinoma (HCC) With Microvascular Invasion (MVI) After Radical Resection
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Recurrence-free Survival (RFS) Time
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 immunotherapy and TACE or to the active comparator (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.
Investigators
Hong Zhao
assistant director physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
- •Adequate hepatic and renal function:
- •Hemoglobin ≥ 9.0g/dl. Absolute neutrophil count (ANC) \> 1,500/mm
- •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.
Exclusion Criteria
- •Recurrent HCC.
- •Portal vein embolus.
- •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.
- •History of Human Immunodeficiency Virus (HIV) or syphilis infection.
- •Severe inflammation, NCI CTCAE Version 3.0 grade \>
- •Epilepsy requiring steroid or antiepileptic drugs.
- •History of allotransplantation.
Outcomes
Primary Outcomes
Recurrence-free Survival (RFS) Time
Time Frame: 12 months
Recurrence-free survival was defined as the interval (in months) between hepatectomy and diagnosis of recurrence using either intrahepatic recurrence or extrahepatic metastasis.
Secondary Outcomes
- Overall Survival (OS) Rate at 24 Months(24 months)