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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Recurrence-free Survival (RFS) Time
Recurrence-free survival was defined as the interval (in months) between hepatectomy and diagnosis of recurrence using either intrahepatic recurrence or extrahepatic metastasis.
Time frame: 12 months
Overall Survival (OS) Rate at 24 Months
Overall survival rate = the number of patients in TACE/TACE+Tcm group survived at 24 months/the number of total patients assigned into TACE/TACE+Tcm group.
Time frame: 24 months
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