SBRT or TACE for Advanced HCC

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized study of stereotactic body radiation therapyRANDOMIZED STUDY OF STER (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: International Atomic Energy Agency
• Treatments: Doxorubicin

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