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Study of the benefit of lenvatinib treatment in waiting list of liver transplantation after TACE failure in patients with hepatocellular carcinoma (HCC) : Ta-Len-Tra
EU CTIS ID: 2024-516408-40-00
What this study is testing
To estimate the proportion of LT among patients under lenvatinib with no complete response after 2 TACE
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient presenting with non resectable HCC
- 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 or 34 mcmol/l - 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 < 50 % - Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
- Patient with QT/QTc < 480 ms
- 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
- Initial French AFP score < or = 2
You likely can't join if
- Contraindication of lenvatinib and excipient: 1) Cardiovascular: - Rhythmic or ischemic recent or uncontrolled cardiac disease: Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats (in case of electroporation procedure) - Congestive heart failure New York Heart Association (NYHA) ≥ class 2 - Unstable angina or myocardial infarction within the past 6 months before enrolment - Uncontrolled arterial hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg) 2) Ongoing ascites: 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) 3) Coagulopathy 4) Ongoing infection > Grade 2 according to NCI-current CTCAE . Hepatitis B is allowed if no active replication is present (below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is ongoing
- Pregnant or lactating woman
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study
- History within the past 3 months before enrollment of haemorrhage, gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula
- History of aneurism
See the full eligibility criteria
Who can join
- Patient presenting with non resectable HCC
- 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 or 34 mcmol/l - 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 < 50 % - Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
- Patient with QT/QTc < 480 ms
- 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
- Initial French AFP score < or = 2
- Registered on national waiting list for LT
- Who underwent TACE as a bridge to LT (i.e. persistent active disease, including stable disease or partial response or progression)
- With no complete response after 2 TACE (i.e. persistent active disease, including stable disease or partial response or progression)
- Non eligible for percutaneous ablation
- Informed, written consent obtained from the patient
- Having the rights to French social insurance
- Aged of 18 years or older
What rules you out
- Contraindication of lenvatinib and excipient: 1) Cardiovascular: - Rhythmic or ischemic recent or uncontrolled cardiac disease: Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats (in case of electroporation procedure) - Congestive heart failure New York Heart Association (NYHA) ≥ class 2 - Unstable angina or myocardial infarction within the past 6 months before enrolment - Uncontrolled arterial hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg) 2) Ongoing ascites: 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) 3) Coagulopathy 4) Ongoing infection > Grade 2 according to NCI-current CTCAE . Hepatitis B is allowed if no active replication is present (below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is ongoing
- Pregnant or lactating woman
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study
- History within the past 3 months before enrollment of haemorrhage, gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula
- History of aneurism
- Hypokalemia, hypomagnesemia and hypocalcemia
- Known hypersensitivity to the study drug or excipients in the formulation
- Decompensated cirrhosis (Child-Pugh > A6)
- Prior systemic therapy with oral TKI and/or immunotherapy
- 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
- Recent digestive bleeding associated with portal hypertension (whithin the 3 months prior to inclusion in the study)
- Advanced or Metastatic HCC (BCLC C)
- Persistent proteinuria of NCI-current CTCAE ≥ Grade ≥ Grade 3
- Project of living donor
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.