SBRT or TACE for Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) Versus Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03338647
• Other study ID #: UAarhus HCC
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: Morten Høyer, PhD
• Phone: +45 23282823
• Email: hoyer[@]aarhus.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)
• 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 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• DEB
Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery

Radiation:
• SBRT
High precision radiation therapy to the liver tumor(s)

Locations

Country	Name	City	State
India	Medanta	Delhi	NCT

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	International Atomic Energy Agency

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression (total of local, intra- and extrahepatic)	Modified RECIST	1 year
Secondary	Response	Modified RESIST	3 months
Secondary	Local control of treated tumor	Modified RECIST	1 year
Secondary	Intrahepatic failure	Intrahepatic failure (more than 1 cm away)	1 year
Secondary	Extrahepatic failure	Modified RECIST	1 year
Secondary	Overall survival	Overall survival	1 year
Secondary	Treatment related toxicity	Tox CTC Ver 4.0	1 year
Secondary	Cost-benefit	$ spend on hospitalization and treatment of complications after the treatment	1 year