NCT05171335
Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients
Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatmentThe Methodist Hospital Research InstituteInvestigator-initiated
~50 participants
Updated 2022-09-21 on ClinicalTrials.gov
What's tested:LenvatinibTranscatheter Arterial Chemoembolization
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Tumor Necrosis
Measured over At time of transplant surgery
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Maen Abdelrahim, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adults (≥18 years old) with histologically or cytologically confirmed HCC beyond Milan Criteria
Must be treatment naïve and eligible for TACE procedure
Must be on the liver transplant waiting list and not require any other solid organ transplant
Eastern Cooperative Oncology Group performance status of 0 or 1
Patients with hepatitis B virus (HBV) infection (as characterized by positive HBV surface antigen and/or anti-hepatitis B core antibodies (HBcAbs) with detectable HBV DNA (≥10 IU/mL or above the limit of detection per local laboratory) must receive antiviral therapy at least after study enrollment per institutional practice to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL). Patients must be managed for 6 months after the last dose of study treatment. Antiviral therapy will be concurrent with lenvatinib.
Patients with hepatitis C virus (HCV) infection (as characterized by the presence of detectable HCV RNA or anti-HCV antibody) must be managed per local institutional practice and for 6 months after the last dose of study treatment. Antiviral therapy will be concurrent with lenvatinib.
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner while undergoing active treatment up to 1 week after
Adequate organ and marrow function, as defined below:
Able to swallow orally administered medication
Capable of signing informed consent form (ICF) and complying with the study protocol, in the investigator's judgement
Exclusion
Mixed hepatocellular-cholangiocarcinoma or HCC within Milan criteria
Previously received chemotherapy or immunotherapy for HCC
Child Pugh assessment score greater than or equal to B8
Uncontrolled blood pressure (BP; Systolic BP\>140 mmHg or diastolic BP \>90 mmHg) despite an optimized regimen of antihypertensive medication
Electrolyte abnormalities that have not been corrected
Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening
Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
Participants having \> 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours
Evidence of portal vein thrombosis that precludes the TACE procedure
History of another primary malignancy except for the following:
Active infection, including tuberculosis or human immunodeficiency virus
Known intolerance to lenvatinib or any of the excipients
Females who are breastfeeding or pregnant
Females of childbearing potential who do not agree to use highly effective contraception during the active treatment phase of the study and for 30 days after the last dose of the study treatment
Males who do not agree to use highly effective contraception during the active treatment phase of the study and for 30 days after the last dose of the study treatment
What this trial measures
- Percent Tumor NecrosisAt time of transplant surgery
Percent tumor necrosis measured via pathology of explanted liver at time of transplant