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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

NCT06487663

Hepatocellular Carcinoma Non-resectable Cholangiocarcinoma Non-resectable Liver Metastases +1 more

RECRUITING NA

Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection

NCT02537158

Hepatocellular Carcinoma

UNKNOWN NA

Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

NCT01828762

Primary Hepatocellular Carcinoma

COMPLETED NA

Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo

NCT07239245

Resectable Hepatocellular Carcinoma With High Risk of Recurrence

RECRUITING PHASE2

Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC

NCT03243916

Hepatocellular Carcinoma

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TACE+Tcm group

Experimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.

Group Type EXPERIMENTAL

TACE plus autologous Tcm immunotherapy

Intervention Type COMBINATION_PRODUCT

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 group

Active comparator: TACE to treat HCC.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

TACE:transcatheter arterial chemoembolization.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

TACE

TACE:transcatheter arterial chemoembolization.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No