SBRT or TACE for Advanced HCC

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: SBRT; Drug: DEB

• Registration Number: NCT03338647
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-26
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-12-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	Stereotactic radiation therapy with risk adapted dose prescription
TACE	DEB	Transarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol

Primary Outcome Measures

Name	Time	Method
Progression (total of local, intra- and extrahepatic)	1 year	Modified RECIST

Secondary Outcome Measures

Name	Time	Method
Response	3 months	Modified RESIST
Local control of treated tumor	1 year	Modified RECIST
Overall survival	1 year	Overall survival
Intrahepatic failure	1 year	Intrahepatic failure (more than 1 cm away)
Extrahepatic failure	1 year	Modified RECIST
Treatment related toxicity	1 year	Tox CTC Ver 4.0
Cost-benefit	1 year	$ spend on hospitalization and treatment of complications after the treatment

Trial Locations

Locations (1)

Medanta; 🇮🇳 Delhi, NCT, India