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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation for HCC - Hepatocellular Carcinoma

In this randomly assigned study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.

Official registry: https://clinicaltrials.gov/study/NCT07924943 · AIO-Studien-gGmbH · enrollment listed as 44

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, or The patients will receive two procedures of TACE prior to liver transplantation. The registry lists allocation as randomized. In this randomly assigned study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.

They plan to enroll about 44 people at München. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation A Randomized, 2-arm Phase II Study Comparing the Combination of Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) Versus TACE Alone in Patients With Hepatocellular Carcinoma as Bridging to Liver Transplantation With Regard to Explant Histopathology

Interventions: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, The patients will receive two procedures of TACE prior to liver transplantation

Primary outcome (registry wording): Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Age ≥ 18 years at time of study entry
  • Patients planned for liver transplantation after discussion within a multidisciplinary board
  • Treatment of all lesions by SBRT is feasible as determined by the local physician. The central review board recommendation process has been initiated (i.e. image upload by site)
  • At least one measurable site of disease with spiral CT scan or MRI according to mRECIST for HCC
  • Sufficient liver function (\< Child Pugh B8)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate blood count, liver enzymes and renal function:

Public study contact (from the registry)

Ursula Ehmer, PD Dr. med.

+49 (0) 89 4140-9324

ursula.ehmer@tum.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07924943 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07924943?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07924943?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary