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Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

Inclusion Criteria:

1. Patients with a confirmed diagnosis of HCC according to the EASL criteria for
diagnosis, and staged according to the BCLC criteria

2. Subject is competent and willing to provide written informed consent in order to
participate in the study

3. Adults (male or female) patients ≥ 18 years of age

4. ECOG performance status 0-2 or Child Pugh classification is 0-11

5. Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be
treated superselectively in a single session or both lobes able to be treated within
3-5 weeks. Patient must have at least one tumor lesion that meets the following
criteria: Lesion can be accurately measured in at least one dimension according to
mRECIST criteria

6. No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by
the MRI or CT

7. Proper blood, liver, renal, heart function: testing result within 2 weeks from
registry of this study

8. No current infections requiring antibiotic therapy

9. Not actively on cumarin based anticoagulation or suffering from a known bleeding

10. Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)

11. Expected survival more than 6 months

Exclusion Criteria:

1. ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5

2. Bilirubin levels >3 mg/dl

3. HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread

4. Patients in which any of the following are contraindicated or present:

- The use of doxorubicin


- Hepatic embolization procedures

- WBC < 3000 cells/mm3

- neutrophil < 1500 cells/mm3

- Cardiac ejection fraction < 50 percent assessed by isotopic ventriculography,
echocardiography or MR

- Elevated creatinine greater than or equal to 2.5 mg/dl

- Impaired clotting test (platelet count < 5 x 104/mm3, PT-INR > 2.0)

- AST and/or ALT >5x ULN or, when greater >250 U/L

- Known hepatofugal blood flow

- Arterio-venous shunt

- Arterio-portal shunt

- Main stem portal vein occlusion(point 6 in inclusion criteria)

5. Women who are pregnant or breast feeding

6. Allergy to iodinated contrast used for angiography

7. Tumour burden of more than 50% of liver

8. Patients with objective signs of active bacterial, viral (HIV), or fungal infection

9. Other primary malignancies or evidence of metastatic disease

10. Patients previously treated with anthracyclines (other than doxorubicin).

11. Any co-morbid disease or condition or event that, in the investigator's judgment,
would place the patient at undue risk that would preclude the safe use of DEB-TACE.

12. Under no circumstances should patients be enrolled in this study who is already
participating in another study for treatment of primary liver cancer.

13. Under no circumstances should patients be enrolled in this study who has received any
other embolotherapy (including SIRT) for the treatment of primary liver cancer.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with SAEs

Outcome Description:

• Study Efficacy Goals: Freedom of primary tumor progression at 6 months (EASL and mRECIST) Average time to progression in all patients

Outcome Time Frame:

Up to 90 days

Safety Issue:



Germany: Ethics Commission

Study ID:

TANDEM 2012-001 OUS



Start Date:

December 2012

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • To show safety
  • and efficacy
  • investigational product
  • Carcinoma
  • Carcinoma, Hepatocellular