Back to results

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

Primary Purpose

Hepatocellular Carcinoma, Malignant Neoplasm

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

TACE plus autologous Tcm immunotherapy

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 0.
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.
Female subjects have had a negative blood pregnancy test within 2 week,
Subjects be willing to use appropriate contraception during the trial and 2 weeks after the last administration of immunotherapy.
Radiology such as CT and MRI were performed in 4 weeks before the study.

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 > 2.
Epilepsy requiring steroid or antiepileptic drugs.
History of allotransplantation.
History or any evidence of hemorrhage.
Subjects undergoing renal dialysis.
Pregnancy or breast-feeding.
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
Uncontrolled Ascites by diuretic treatment.
History of encephalopathy.
Gastrointestinal hemorrhage in 30 days before the study.
History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
Major surgery except radical hepatic resection was performed in 4 weeks before the study.
Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial.
Any condition that would interfere with or endanger the safety and compliance of subjects.

Sites / Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TACE+Tcm group

TACE group

Arm Description

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

Active comparator: TACE to treat HCC.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03575806

First Posted

June 12, 2018

Last Updated

June 3, 2020

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Newish Technology (Beijing) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03575806

Brief Title

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

Official Title

A Single-center, Open-label, Exploratory Trial of Autologous Immunotherapy for Hepatocellular Carcinoma (HCC) With Microvascular Invasion (MVI) After Radical Resection

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 9, 2017 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Newish Technology (Beijing) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Malignant Neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TACE+Tcm group

Arm Type

Experimental

Arm Description

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

Arm Title

TACE group

Arm Type

Active Comparator

Arm Description

Active comparator: TACE to treat HCC.

Intervention Type

Combination Product

Intervention Name(s)

TACE plus autologous Tcm immunotherapy

Intervention Description

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

Procedure

Intervention Name(s)

TACE

Intervention Description

TACE:transcatheter arterial chemoembolization.

Primary Outcome Measure Information:

Title

Recurrence-free Survival (RFS) Time

Description

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

Secondary Outcome Measure Information:

Title

Overall Survival (OS) Rate at 24 Months

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 0. 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. Female subjects have had a negative blood pregnancy test within 2 week, Subjects be willing to use appropriate contraception during the trial and 2 weeks after the last administration of immunotherapy. Radiology such as CT and MRI were performed in 4 weeks before the study. 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 > 2. Epilepsy requiring steroid or antiepileptic drugs. History of allotransplantation. History or any evidence of hemorrhage. Subjects undergoing renal dialysis. Pregnancy or breast-feeding. 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 Uncontrolled Ascites by diuretic treatment. History of encephalopathy. Gastrointestinal hemorrhage in 30 days before the study. History of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage. Major surgery except radical hepatic resection was performed in 4 weeks before the study. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study. Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study. Drug abuse, medical treatment, mental illness or social disorders that would interfere with subjects' participation, or confound the results of the trial. Any condition that would interfere with or endanger the safety and compliance of subjects.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hong Zhao

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34926296

Citation

Cai J, Zhao J, Liu D, Xie H, Qi H, Ma J, Sun Z, Zhao H. Efficacy and Safety of Central Memory T Cells Combined With Adjuvant Therapy to Prevent Recurrence of Hepatocellular Carcinoma With Microvascular Invasion: A Pilot Study. Front Oncol. 2021 Dec 3;11:781029. doi: 10.3389/fonc.2021.781029. eCollection 2021.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs