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Hepatocellular CarcinomaNCT04738188

Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria;

A study testing DEB-TACE, cTACE and Drug-eluting Beads in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
DEB-TACE, cTACE and Drug-eluting Beads
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteChina
Study dates
18 Mar 2020to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 70 years of age, of any sex;
  • Patients who have histopathological or cytological proof of hepatocellular carcinoma (HCC) or meet the diagnostic criteria of Diagnosis, management, and treatment of hepatocellular carcinoma(V2017);
  • Beyond UCSF criteria: Diameter of single HCC lesion is between 6.5 cm and 10 cm; The number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; Multiple HCC lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. Patients cannot be treated with resection or liver transplantation;
  • Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;
  • Child-Pugh's grade A or B (no more than 7 score);
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
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  • Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;
  • The function of main organs is normal and meet the following criteria:
  • 1) Outcome of blood routine must meet the following criteria (No blood transfusion or blood products were performed within 4 days, and no g-CSF or other hematopoietic stimulants were used for correction): i. Hemoglobin(HB)≥90 g/L; ii. Absolute neutrophil count (ANC)≥1.5×109/L； iii. Platelet (PLT)≥80×109/L; 2) Outcome of hemal biochemistry examination meet the following criteria: i. Albumin (ALB) ≥29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5 × upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤2 × ULN; iv. Serum creatinine (SCr) ≤1.25 × ULN, or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula); 3) Patients who have normal livers with an Remnant Liver Volume (RLV)/Standard Liver Volume(SLV) >20% ; Patients who have cirrhosis with an RLV/SLV>40%; 9. Life expectancy of > 3 months; 10. Patients volunteered to participate in this study and signed informed consent, with good compliance.Exclusion Criteria.

Who cannot join

  • Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;
  • Patients with diffuse liver cancer;
  • Patients with myocardial ischemia, myocardial infarction or poor controlled arrhythmia (including QTc≥470 ms) beyond stage Ⅱ; according to New York Heart Association (NYHA) standard, patients with heart failure in stage Ⅲ～Ⅳ; patients with an left ventricular ejection fraction(LVEF) <50%;
  • Abnormal coagulation （International Normalized Ratio(INR)>1.5, Prothrombin Time(PT)>ULN+4s or Activated Partial Thromboplastin Time (APTT) >1.5 ×ULN）,or patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • Patients unsuitable for the study in the opinion of the Investigator;
  • Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;
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  • Patients with mental disorders or history of abuse of psychotropic substances;
  • Infection with human immunodeficiency virus (HIV);
  • A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;
  • Patients with active infection;
  • Patients with contraindications to TACE or epirubicin;
  • Floating population or with poor compliance;
  • Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.

Trial locations and contacts

1 site in 1 country.

Jiahong Dong, MD contact

01056118763

dongjiahong@mail.tsir

China1 site, 1 recruiting

  • Beijing Tsinghua Chang Gung Hospital

    Beijing

    Jiahong Dong, 13240009509

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria: a Multi-center, Randomized, Parallel-controlled Study

This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria.

Being tested
DEB-TACE, cTACE, Drug-eluting Beads, Epirubicin
Keywords
Hepatocellular Carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • DEB-TACEProcedure or surgery

    Drug-eluting beads transcatheter arterial chemoembolization

  • cTACEProcedure or surgery

    Transcatheter arterial chemoembolization

  • Drug-eluting BeadsDevice

    Drug-eluting beads

  • EpirubicinDrug

    Chemotherapy drug for intra-arterial infusion

Study groups in NCT04738188
Study groupRoleWhat they receive
Drug-eluting bead transarterial chemoembolization(DEB-TACE)ExperimentalNot described
Receives: Procedure: DEB-TACE; Device: Drug-eluting Beads; Drug: Epirubicin
conventional transarterial chemoembolization(cTACE)Active comparatorNot described
Receives: Procedure: cTACE; Drug: Epirubicin

What is being measured

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

  1. Downstaging success rate

    Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection.

    Measured: Within 6 months after surgery

Secondary outcomes (13)

  1. Complete response (CR)

    Disappearance of any intratumoral arterial enhancement in all target lesions

    Measured: 1, 3, 6 months after surgery

  2. Partial response (PR)

    At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions

    Measured: 1, 3, 6 months after surgery

  3. Stable disease (SD)

    Number of the subjects that do not qualify for partial response or progressive disease measured by modified Response Evaluation Criteria in Solid Tumors( mRECIST) criteria

    Measured: up to 6months after TACE procedure

  4. Progressive disease (PD)

    An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started

    Measured: 1, 3, 6 months after surgery

  5. Objective response (OR)

    CR+PR

    Measured: 1, 3, 6 months after surgery

  6. Duration of downstaging

    Interval between initial TACE treatment and the success or failure of downstaging according to the UCSF criteria assessed by the dynamic enhanced CT ;

    Measured: within 36 months

  7. Times of TACE treatments

    Times of TACE surgery

    Measured: within 36 months

  8. Changes of tumor biomarkers (AFP, PIVKA-Ⅱ)

    AFP and PIVKA-II must be measured at 1week before, 1 week,1month after TACE or curative treatment; AFP ,PIVKA-II could be measured every 3-6 months during follow up according to the availability of equipment at the site

    Measured: From 7 days before TACE or curative treatments to the endpoints of the trial.(Up to 36 months)

  9. Changes in liver function

    Changes of the Child-pugh Score that used to assess the prognosis of chronic liver disease,consisting of 5 items(ascites,total bilirubin，albumin,prothrombin time and degree of encephalopathy),of which is scored 1-3 points,with 3 indicating greatest severity)

    Measured: from the date of the first TACE to the end of the clinical trial or the death of the patient，Up to 36months

  10. Tumor-free survival (TFS)

    as the time from surgery initiation to tumor recurrence or death from any cause

    Measured: Within 36 months

  11. Progression-free survival (PFS)

    as the time from surgery initiation to disease progression or death from any cause

    Measured: Within 36 months

  12. Overall survival (OS)

    as the time from surgery initiation to death from any cause

    Measured: Within 36 months

  13. Recurrence rate of Hepatocellular carcinoma

    Recurrence rate of hepatocellular carcinoma

    Measured: Within 36 months

Timeline

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

  1. First posted4 Feb 2021
  2. Study start18 Mar 2020
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2025 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738188
Sponsor's protocol ID
19229-0-02
Status last verified
Feb 2021
First submitted
23 Nov 2020
Last updated
4 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DEB-TACE, cTACE and Drug-eluting Beads in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital 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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Jiahong Dong, MD (01056118763, dongjiahong@mail.tsir), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Downstaging success rate (time frame: Within 6 months after surgery). 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 NCT04738188.

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 4 Feb 2021.

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