SBRT or TACE for Advanced HCC

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03338647
• Date of registration: 01/11/2017
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: SBRT or TACE for Advanced HCC
• Scientific title: Randomized Study of Stereotactic Body Radiation Therapy (SBRT) Versus Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma
• Date of first enrolment: October 26, 2017
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03338647
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Tejinder Kataria, Dr

• Name: Morten Høyer, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- • 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)
Raoul et al (2011)

- 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).

- 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 antineplastic 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

Radiation: SBRT

Drug: DEB

Primary Outcome(s)

Progression (total of local, intra- and extrahepatic) [Time Frame: 1 year]

Secondary Outcome(s)

Response [Time Frame: 3 months]

Extrahepatic failure [Time Frame: 1 year]

Cost-benefit [Time Frame: 1 year]

Intrahepatic failure [Time Frame: 1 year]

Overall survival [Time Frame: 1 year]

Local control of treated tumor [Time Frame: 1 year]

Toxicity [Time Frame: 1 year]

Secondary ID(s)

UAarhus HCC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Atomic Energy Agency