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Liver NeoplasmsPhase 2HepSTARNCT02958163

Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)

A Phase 2 study testing Trans-arterial Chemo-Embolization, Doxorubicin and Stereotactic Ablative Radiotherapy in people with Liver Neoplasms and Hepatocellular Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 5 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Neoplasms, Hepatocellular Cancer
What is being tested?
Trans-arterial Chemo-Embolization, Doxorubicin and Stereotactic Ablative Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
5 sitesBelgium
Study dates
20 Feb 2017to 17 Oct 2017
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by:
  • dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out
  • histopathology
  • satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable
  • Hepatocellular carcinoma belonging to Barcelona Clinic Liver Cancer Stage System class B
  • Tumor must be measurable on a multi-phase MRI according to mRECIST criteria
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  • Non-tumoral liver volume ≥ 800 cc
  • Child-Pugh (CP) A to B7 cirrhosis
  • HCC Patients can be included if they require treatment prior to liver transplantation
  • ECOG performance status 0-1
  • AST/ALT < 5 times ULN
  • Initial platelets ≥ 50 000 x 10E9/l, neutrophils > 1500 x 10E9/l, Hb > 9 g/dl
  • Serum creatinine < 1.5 X normal, or calculated Creatinine clearance rate ≥ 60 mL/min
  • As tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. Cholangiocarcinoma cannot be included.
  • Written informed consent form to be signed,
  • Patient willing and able to comply to the follow-up schedule
  • Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Who cannot join

  • Eligibility for resection or ablative treatments
  • Extra hepatic spread of the disease
  • Previous treatment of the same lesion with TACE
  • Previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen
  • Uncontrolled Ascites
  • Uncontrolled Encephalopathy
Show all 9Show fewer
  • Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required)
  • Known current pregnancy
  • Uncontrolled active co-morbidity

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • Cliniques Universitaires Saint Luc

    Brussels, Woluwé Saint Lambert, 1200

  • Institut Jules Bordet/Hôpital Erasme

    Brussels, 1000

  • Hôpital de JOLIMONT

    Jolimont, Hainaut, 7100

  • Centre Hospitalier Universitaire/CHC Saint Joseph

    Liège, Liège, 4000

  • Clinique et Maternité Sainte Elisabeth/CHU Mont Godinne

    Namur, 5000

Other trials in Belgium

About this study

Official title: Randomized Controlled Phase II Trial Comparing Trans-Arterial Chemo-Embolization (TACE) With TACE Plus Stereotactic Ablative Radiotherapy (SABR) in Stage BCLC B Hepatocarcinoma (HepSTAR)

This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.

This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.

Read the detailed description

The patients will be randomized in 2 arms determining the treatment they will receive:

Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR

Being tested
Trans-arterial Chemo-Embolization, Doxorubicin, Stereotactic Ablative Radiotherapy
Keywords
Hepatocellular cancer, Stereotactic Body Radiotherapy, Chemoembolization, Therapeutic
Medical subject headings
Liver Neoplasms

What participants receive

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

  • Trans-arterial Chemo-EmbolizationProcedure or surgery

    Also called TACE

    Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.

  • DoxorubicinDrug

    Also called DEB-TACE

    Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.

  • Stereotactic Ablative RadiotherapyRadiation

    Also called SABR

    SABR schemes will be adapted according to the CP score and the vicinity of surrounding organs at risk. These are the different schemes proposed in this trial:

    48Gy = 3x16Gy BED 124.8Gy ( α/β=10) 50Gy = 5x10Gy BED 100Gy ( α/β=10) 48Gy = 6x8Gy BED 86.4Gy ( α/β=10) 40Gy = 5x8Gy BED 72Gy ( α/β=10)

    For patients with Child-Pugh (CP) A cirrhosis : the choice of the scheme will be left to each physician. The highest BED should be favored if dose constraints to the organs at risk are respected.

    For patients with CP B cirrhosis : only the latter scheme will be allowed: 40Gy = 5x8Gy.

Study groups in NCT02958163
Study groupRoleWhat they receive
Trans-Arterial Chemo-embolization (TACE)Active comparatorTrans-arterial Embolisation will be performed with drug-eluting beads loaded with Doxorubicin. First session will be given within 4 weeks after randomization. 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last session of TACE corresponds to the treatment completion date.
Receives: Procedure: Trans-arterial Chemo-Embolization; Drug: Doxorubicin
TACE+Stereotactic Ablative RadiotherapyExperimentalThe first part of the treatment, which is the DEB-TACE delivery, will be exactly the same than in arm A. The radiotherapy (SABR) will then start within 4 to 6 weeks after. Afterwards, 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last SABR fraction or the last session of TACE corresponds to the treatment completion date.
Receives: Procedure: Trans-arterial Chemo-Embolization; Drug: Doxorubicin; Radiation: Stereotactic Ablative Radiotherapy

What is being measured

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

  1. Objective response rate at 6 months

    Objective response rate including complete and partial response based on the MRI evaluation (mRECIST)

    Measured: 6 months after the completion of treatment

Secondary outcomes (13)

  1. Time to progression

    defined as the time between the end of treatment and the occurrence of a local recurrence. The diagnoses of another intra- or extra-hepatic lesion of HCC will not be considered as progression

    Measured: 1 year after the treatment completion

  2. Time to untreatable progression

    defined as the time between the end of treatment and the occurrence of untreatable intra-hepatic disease

    Measured: 1 year after the treatment completion

  3. 6-months overall survival

    defined as survival rate of patients at 6months after the end of treatment

    Measured: 1 year after the treatment completion

  4. 1-year overall survival

    defined as survival rate of patients at 1 year after the end of treatment

    Measured: 1 year after the treatment completion

  5. Acute toxicities

    Acute toxic events will have to be described and recorded in accordance with the CTCAE 4.03 (Common Terminology Criteria for Adverse events).

    Measured: 6 months after treatment completion

  6. Late toxicities

    Late toxic events will have to be described and recorded in accordance with the CTCAE 4.03 (Common Terminology Criteria for Adverse events).

    Measured: 6 months after treatment completion

  7. Quality of life assessment by questionnaire at baseline

    Quality of life will be assessed by questionnaires: EORTC QLQC30. The investigators will ask each patient to answer to these questionnaires once at randomization.

    Measured: baseline

  8. Quality of life assessment by questionnaire at 2 months

    Quality of life will be assessed by questionnaires: EORTC QLQC30. The investigators will ask each patient to answer to these questionnaires 2 months after treatment completion

    Measured: 2 months

  9. Quality of life assessment by questionnaire at 6 months

    Quality of life will be assessed by questionnaires: EORTC QLQC30. The investigators will ask each patient to answer to these questionnaires 6 months after treatment completion

    Measured: 6 months after treatment completion

  10. Assessment by questionnaires of specific for hepatocarcinoma quality of life at baseline

    Quality of life will be assessed by questionnaires specific for patients with hepatocarcinoma:EORTC QLQH18. The investigators will ask each patient to answer to these questionnaires once at randomization.

    Measured: baseline

  11. Assessment by questionnaires of specific for hepatocarcinoma quality of life at 2 months

    Quality of life will be assessed by questionnaires specific for patients with hepatocarcinoma:EORTC QLQH18. The investigators will ask each patient to answer to these questionnaires 2 months after treatment completion

    Measured: 2 months after treatment completion

  12. Assessment by questionnaires of specific for hepatocarcinoma quality of life at 6 months

    Quality of life will be assessed by questionnaires specific for patients with hepatocarcinoma:EORTC QLQH18. The investigators will ask each patient to answer to these questionnaires 6 months after treatment completion

    Measured: 6 months after treatment completion

  13. Overall response rate based on the MRI evaluation in Child Pugh B7 patients

    As the choice of the irradiation scheme will be influenced by the severity of the underlying cirrhosis with a Child Pugh score B7, the overall response rate in this specific kind of patients will be separately measured besides the overall response rate of the whole cohort.

    Measured: 6 months

Timeline

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

  1. First posted8 Nov 2016 (estimated)
  2. Study start20 Feb 2017
  3. Primary completion17 Oct 2017
  4. Study completion17 Oct 2017

Why it stopped: lack of recruitment

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02958163
Sponsor's protocol ID
28248368
Acronym
HepSTAR
Status last verified
Mar 2017
First submitted
26 Oct 2016
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Every participant data will be anonymized for the trial purpose.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trans-arterial Chemo-Embolization, Doxorubicin and Stereotactic Ablative Radiotherapy in people with Liver Neoplasms and Hepatocellular Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 5 sites in Belgium.

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 17 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. 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?

The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.

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?

Objective response rate at 6 months (time frame: 6 months after the completion of treatment). 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 NCT02958163.

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 7 Nov 2017.

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HepSTAR Clinical Trial NCT02958163 | AzTrials