Hepatocellular CarcinomaPhase 3NCT03338647
SBRT or TACE for Advanced HCC
A Phase 3 study testing DEB and SBRT in people with Hepatocellular Carcinoma, run by University of Aarhus at 1 site in India.
Trial summary
Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- DEB and SBRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 26 Oct 2017to 31 Dec 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC (biopsy or radiological diagnostic (>1 cm, enhancing in arterial phase and wash-out in later phases).
- Number of lesions: not more than 3 lesions
- Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
- Child-Pugh A or B (<7) on examination within 6 weeks prior to study entry
- BCLC Stage A/B
- Must be fit (eligible) for SBRT and TACE
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- Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
- Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is >10 mm
- All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥50,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Total bilirubin < 2 mg/dL
- Prothrombin time/INR < 1.4 (unless on Coumadin/Warfarin)
- Albumin ≥ 28 g/L
- AST (and ALT) < 5 times ULN
- Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min
- Left-ventricular ejection fraction >50% (cardiac ejection fraction should be measured in case of history of cardio-vascular disease.
- May have had previous surgery, ethanol injection and RFA to the liver
Who cannot join
- • Not suitable for clinical trial or follow-up
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy.
- Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE)
- Non-enhancing HCC on CT or CT-angio or
- Portal vein thrombosis/macroscopic venous invasion
- Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug).
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- Evidence of metastatic disease including nodal or distant metastases.
- Previous TACE or radiation to the liver (including SIRT)
- Life-threatening condition (including untreated HIV and active hepatitis B/C)
- Detectable HBeAg and HBV viral load > 20,000 IU/mL or
- HBeAg-negative chronic hepatitis B and HBV viral load >2,000 IU/mL
- If HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks.
- If anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease. Active HCV should be treated sufficiently before inclusion in the study. Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy.
- Patients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial
- On sorafenib or other antineoplastic drug therapy within 7 days before inclusion (not accepted until time of progression).
- Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Medanta
Delhi, National Capital Territory of Delhi, 122001
Tejinder Kataria, Dr
About this study
Official title: Randomized Study of Stereotactic Body Radiation Therapy (SBRT) Versus Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma
Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB, SBRT
- Keywords
- Stereotactic body radiation therapy, transarterial chemoembolization, SBRT, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEBDrug
Also called doxorubicin
Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery
SBRTRadiation
High precision radiation therapy to the liver tumor(s)
| Study group | Role | What they receive |
|---|---|---|
| TACE | Active comparator | Transarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol Receives: Drug: DEB |
| SBRT | Experimental | Stereotactic radiation therapy with risk adapted dose prescription Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression (total of local, intra- and extrahepatic)
Modified RECIST
Measured: 1 year
Secondary outcomes (7)
Response
Modified RESIST
Measured: 3 months
Local control of treated tumor
Modified RECIST
Measured: 1 year
Intrahepatic failure
Intrahepatic failure (more than 1 cm away)
Measured: 1 year
Extrahepatic failure
Modified RECIST
Measured: 1 year
Overall survival
Overall survival
Measured: 1 year
Treatment related toxicity
Tox CTC Ver 4.0
Measured: 1 year
Cost-benefit
$ spend on hospitalization and treatment of complications after the treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start26 Oct 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338647
- Sponsor's protocol ID
- UAarhus HCC
- Status last verified
- May 2021
- First submitted
- 1 Nov 2017
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Stereotactic Body Radiation Therapy (SBRT) Versus Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03338647
- Acronym / sponsor ID
- UAarhus HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Stereotactic body radiation therapy, transarterial chemoembolization, SBRT, TACE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE | Active comparator | Drug: DEBTransarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol |
| SBRT | Experimental | Radiation: SBRTStereotactic radiation therapy with risk adapted dose prescription |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- HCC (biopsy or radiological diagnostic (>1 cm, enhancing in arterial phase and wash-out in later phases).
- Number of lesions: not more than 3 lesions
- Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
- Child-Pugh A or B (<7) on examination within 6 weeks prior to study entry
- BCLC Stage A/B
Key exclusion criteria (16 listed)
- • Not suitable for clinical trial or follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEBAlso: doxorubicinInfusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery | Drug | TACE |
| SBRTHigh precision radiation therapy to the liver tumor(s) | Radiation | SBRT |
Primary outcome
Progression (total of local, intra- and extrahepatic)
Time frame: 1 year
Modified RECIST
7 secondary outcomes
Response
Time frame: 3 months
Local control of treated tumor
Time frame: 1 year
Intrahepatic failure
Time frame: 1 year
Extrahepatic failure
Time frame: 1 year
Overall survival
Time frame: 1 year
Treatment related toxicity
Time frame: 1 year
Cost-benefit
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: Yes. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DEB and SBRT in people with Hepatocellular Carcinoma, run by University of Aarhus at 1 site in India.
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 19 inclusion and 16 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 2 Dec 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Morten Høyer, PhD (+45 23282823, hoyer@aarhus.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression (total of local, intra- and extrahepatic) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2021.