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Hepatocellular CarcinomaPhase 2NCT03575806

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

A Phase 2 study testing TACE plus autologous Tcm immunotherapy and TACE in people with Hepatocellular Carcinoma and Malignant Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma, Malignant Neoplasm
What is being tested?
TACE plus autologous Tcm immunotherapy and TACE
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
9 Jan 2017to 31 Oct 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

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

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).

Read the 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.

Being tested
TACE plus autologous Tcm immunotherapy, TACE
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACE plus autologous Tcm immunotherapyCombination 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.

  • TACEProcedure or surgery

    TACE:transcatheter arterial chemoembolization.

Study groups in NCT03575806
Study groupRoleWhat they receive
TACE+Tcm groupExperimentalExperimental arm: TACE plus autologous Tcm immunotherapy to treat HCC.
Receives: Combination Product: TACE plus autologous Tcm immunotherapy
TACE groupActive comparatorActive comparator: TACE to treat HCC.
Receives: Procedure: TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start9 Jan 2017
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575806
Sponsor's protocol ID
CancerIHCAMS-HCC-Tcm
Status last verified
May 2020
First submitted
12 Jun 2018
Last updated
11 Jun 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34926296

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TACE plus autologous Tcm immunotherapy and TACE in people with Hepatocellular Carcinoma and Malignant Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free Survival (RFS) Time (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03575806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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