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RecruitingPhase 1interventionalRules rewrite

Phase 1: Surgery with Neoadjuvant stereotactic body radiation therapy for Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".

Official registry: https://clinicaltrials.gov/study/NCT04587739 · University Hospital, Lille · enrollment listed as 30

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

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 Surgery with Neoadjuvant stereotactic body radiation therapy. The registry lists allocation as na. Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection.

They plan to enroll about 30 people at Lille. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.

Interventions: Surgery with Neoadjuvant stereotactic body radiation therapy

Primary outcome (registry wording): Drop-out rate

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria
  • Single nodule, 3 to 8 cm of largest diameter
  • Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization

Public study contact (from the registry)

Emmanuel Boleslawski, MD,PhD

320444260

emmanuel.boleslawski@chru-lille.fr

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 NCT04587739 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 NCT04587739?

Phase 1. 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 NCT04587739?

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