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

NCT02958163 | Terminated Phase 2

• 1 other identifier: 28248368
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Liver Neoplasms; Hepatocellular Cancer

Keywords

Hepatocellular cancer; Stereotactic Body Radiotherapy; Chemoembolization, Therapeutic

Outcome Measures

Primary Outcomes (1)

• Objective response rate at 6 months

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

  6 months after the completion of treatment

Secondary Outcomes (13)

• Time to progression

  1 year after the treatment completion

• Time to untreatable progression

  1 year after the treatment completion

• 6-months overall survival

  1 year after the treatment completion

• 1-year overall survival

  1 year after the treatment completion

• Acute toxicities

  6 months after treatment completion

Other Outcomes (8)

• Immuno-histochemical detection of tumoral markers on biopsy (AFP/CK19/DCP)

  at time of biopsy

• Baseline biological detection of tumoral marker(s) : AFP +/- DCP

  at baseline

• Biological detection of tumoral marker(s) (AFP +/- DCP) at 2 months after treatment

  2 months after treatment completion

Study Arms (2)

Trans-Arterial Chemo-embolization (TACE)

ACTIVE COMPARATOR

Trans-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.

Procedure: Trans-arterial Chemo-Embolization; Drug: Doxorubicin

TACE+Stereotactic Ablative Radiotherapy

EXPERIMENTAL

The 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.

Procedure: Trans-arterial Chemo-Embolization; Drug: Doxorubicin; Radiation: Stereotactic Ablative Radiotherapy

Interventions

Trans-arterial Chemo-Embolization PROCEDURE

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

Also known as: TACE

TACE+Stereotactic Ablative Radiotherapy; Trans-Arterial Chemo-embolization (TACE)

Doxorubicin DRUG

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

Also known as: DEB-TACE

TACE+Stereotactic Ablative Radiotherapy; Trans-Arterial Chemo-embolization (TACE)

Stereotactic Ablative Radiotherapy RADIATION

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.

Also known as: SABR

TACE+Stereotactic Ablative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Written informed consent form to be signed,
• Patient willing and able to comply to the follow-up schedule

You may not qualify if:

• 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
• Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required)
• Known current pregnancy
• Uncontrolled active co-morbidity

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Erasme University Hospital: collaborator
• Jules Bordet Institute: collaborator
• University of Liege: collaborator
• Clinique Saint Joseph, Liège: collaborator
• Centre Hospitalier Universitaire UCLouvain Namur: collaborator

Study Sites (5)

Hôpital de JOLIMONT

Jolimont, Hainaut, 7100, Belgium

Location

Centre Hospitalier Universitaire/CHC Saint Joseph

Liège, Liège, 4000, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, Woluwé Saint Lambert, 1200, Belgium

Location

Institut Jules Bordet/Hôpital Erasme

Brussels, 1000, Belgium

Location

Clinique et Maternité Sainte Elisabeth/CHU Mont Godinne

Namur, 5000, Belgium

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Xavier GEETS

  Cliniques Universitaires Saint Luc/MIRO

  PRINCIPAL INVESTIGATOR

• Ivan BORBATH

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 8, 2016
• Study Start: February 20, 2017
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)