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Cancer pill may boost ablation success in aggressive liver tumors

NCT ID NCT05113186

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the targeted drug lenvatinib, given before and after a standard tumor-burning procedure (ablation), can help prevent liver cancer from returning in patients with aggressive tumors. About 32 adults with high-risk features (like high AFP levels or infiltrative tumors) will receive lenvatinib for 21 days before ablation and for 3 months after. The main goal is to see if this combination improves local recurrence-free survival at one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lenvatinib (a targeted cancer pill)
What this could lead to
If it works, this could point toward a way to lower the chance of liver cancer coming back after ablation in patients with aggressive tumors.
What could go wrong
This is a very small, early-phase trial with only 32 participants. It may not show a clear benefit, and lenvatinib can cause side effects like high blood pressure, fatigue, and liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients ≥ 18 years * Histological or radiological diagnosis of HCC, whether new or recurrent following a prior curative therapeutic management \> 6 months. * Barcelona Clinical Liver Cancer (BCLC) stage Category A * Comprising at least one of the following the following characteristics: * Single tumour\>3 cm≤ 5cm or * Multiple tumours (max 3 lesions ≤ 3cm) or * Single tumour between 2 and 3 cm with at least one of the following characteristic: * Serum AFP\>100 ng/mL * Infiltrative form * Macro-trabecular subtype (if applicable) * Patients with HCC amenable for PA as assessed by multidisciplinary board * At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC * Absence of any portal vein thrombosis * Liver function status Child-Pugh Class A * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Adequate bone marrow, liver and renal function as assessed by the following laboratory tests: * Hemoglobin \> 8.5 g/dL * Absolute neutrophil count ≥ 1500/mm3 (≥ 1200/mm3 for black/African, American) * Platelet count ≥ 60,000/ mm3 * Total bilirubin ≤ 2 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) * Serum creatinine ≤ 1.5 x ULN * Prothrombine time-international normalized ratio (PT-INR) \< 2.3 and PTT \< 1.5 * Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2 * Life expectancy ≥ 3 months * Women of childbearing potential (WOCBP) need to accept one effective method of contraception until 1 month after the last lenvatinib intake and avoid pregnancy * Patients who are sexually active with WOCBP partners need to accept one effective method of contraception until 1 month after lenvatinib intake and men must agree to use adequate contraception * Patients affiliated to a Social Security System * Written informed consent signed * Patient under guardianship or curatorship\* * Satisfactory nutritional status (BMI\>18 kg/m² for patients under 70 years old, or ≥21 kg/m² for the patients over 70 years old) * Patient under guardianship or curatorship\* Exclusion Criteria: * Patients with recurrence of HCC occurring less than six months after a curative treatment regarded as successful * BCLC stage \>A (1 single lesion \>5cm or more than 3 lesions ore multifocal HCC \>3cm or vascular invasion or extra-hepatic spread) * Patients with contraindications to PA * Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats (in case of electroporation procedure) * Ascites * Coagulopathy * Ongoing bacterial infection * Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate * Prior liver transplantation * Prior systemic treatment for HCC (chemotherapy, any other TKI, immunotherapy) * Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention * Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or non-melanoma skin cancer and superficial bladder tumours. Any cancer curatively treated \> 3 years prior to study entry is permitted * Major surgical procedure or significant traumatic injury within 28 days before enrolment * Congestive heart failure New York Heart Association (NYHA) ≥ class 2 * Unstable angina or myocardial infarction within the past 6 months before enrolment * Uncontrolled blood pressure to systolic BP \>140mmHg or diastolic BP \>90 mmHg in spite of an optimized regimen of antihypertensive medication. * Patients with phaeochromocytoma * Refractory ascites according to EASL guidelines definition (ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment) * Persistent proteinuria of NCI-CTCAE version 4.0 ≥ Grade 3 * Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.0. Hepatitis B is allowed if no active replication is present (below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is required * Clinically significant bleeding NCI-CTCAE version 4.0 ≥ Grade 3 within 30 days before enrolment * Any psychological, familial, sociological, geographical or illness or medical condition that could jeopardize the safety of the patient and/or his compliance with the study protocol and follow-up procedure * Non-healing wound, ulcer or bone fracture * Known hypersensitivity to the study drug or excipients in the formulation * Any malabsorption condition * Breast feeding * Pregnancy * Patient unable to swallow oral medication

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NAHON

    Bobigny, 93000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.