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Compares treatment options for Hepatocellular Carcinoma (HCC)
Official title Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy
ClinicalTrials.gov ID: NCT07493668
What this study is testing
What is Fostrox?
Fostrox is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of fostrox in combination with lenvatinib compared with lenvatinib alone in patients with locally advanced or unresectable advanced hepatocellular carcinoma (HCC) who have experienced radiologically confirmed disease progression following first-line combination immunotherapy. Approximately 80 patients will be enrolled at 9 study sites and randomized in a 1:1 ratio to 1 of 2 treatment arms: fostrox plus lenvatinib or lenvatinib alone.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients with a diagnosis of locally advanced or unresectable metastatic HCC confirmed by radiology, histology, or cytology
- Received at least 2 cycles of first-line systemic therapy with immunotherapy (IO) combination (atezolizumab + bevacizumab, ipilimumab + nivolumab, or...
- Patients with measurable lesion in the liver (at least one target lesion) according to RECIST v1.1 and mRECIST \- Patients who received prior local...
- Patients who are not amenable for curative surgery or locoregional therapy
- ECOG performance status of 0 or 1 within 7 days prior to randomization
You likely can't join if
- Patients who have received more than 1 prior systemic therapy (i.e., fostrox + lenvatinib or lenvatinib must be administered as second-line treatment)
- Patients who have received first-line systemic therapy for locally advanced unresectable or metastatic HCC other than an IO combination
- Patients who have received a prior TKI (e.g. lenvatinib, regorafenib, cabozantinib etc.) in the IO combination
- Patients with a history of hypersensitivity to lenvatinib or any of its components (active ingredient or excipients)
- Patients with fibrolamellar HCC, sarcomoid HCC, or a mix of HCC and intrahepatic cholangiocarcinoma (iCCA)
- Patients with central nervous system metastasis
See the full eligibility criteria
Who can join
- Patients with a diagnosis of locally advanced or unresectable metastatic HCC confirmed by radiology, histology, or cytology
- Received at least 2 cycles of first-line systemic therapy with immunotherapy (IO) combination (atezolizumab + bevacizumab, ipilimumab + nivolumab, or durvalumab + tremelimumab), with radiologically confirmed disease...
- Patients with measurable lesion in the liver (at least one target lesion) according to RECIST v1.1 and mRECIST \- Patients who received prior local therapy (e.g., radiofrequency ablation, cryoablation, percutaneous...
- Patients who are not amenable for curative surgery or locoregional therapy
- ECOG performance status of 0 or 1 within 7 days prior to randomization
- Life expectancy of at least 3 months
- people age ≥19 years at the time of signing the informed consent form (ICF)
- people who are capable of providing signed informed consent to comply with requirements and limitations described in the ICF and this protocol and express obvious and voluntary agreement prior to the start of the study
- people with adequate hematological function and hepatic function without using blood transfusion or growth factors within 7 days prior to randomization
- Hemoglobin (Hb) ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/μl
- Platelet count ≥75,000/μl
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) estimated by Cockcroft-Gault equation ≥60 mL/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5.0 x ULN
- Serum total bilirubin ≤3.0 x ULN
- International normalized ratio (INR) ≤1.5 or prothrombin time ≤1.5 x ULN
- Activated partial thromboplastin time (aPTT) ≤1.5 x ULN
- Child Pugh A within 7 days prior to randomization
- Negative HIV test at screening
- Documented hepatitis virus status for HBV and HCV confirmed at screening
- For patients with active HBV: HBV DNA \<500 IU/mL during screening; initiation of antiviral therapy at least 14 days prior to randomization; willingness to continue antiviral therapy during the study
- For patients with active or past HCV infection: confirmed negative viral load using HCV PCR
- For patients with concurrent HBV and HCV infection: not eligible
- Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤1 before participation, except alopecia
- Patients with a prior history of gastric or esophageal variceal bleeding may be eligible if they have received appropriate treatment with no evidence of recurrent bleeding for at least 6 months, have no high-risk...
- Female people
- Eligible if postmenopausal
- Female patient who is a woman of childbearing potential (WOCBP) (post menarchal) who agrees to use a highly efficient method of contraception (a method with less than 1% failure rate [e.g. sterilization, hormone...
- WOCBP must have a negative urine pregnancy test at screening and negative urine pregnancy test within 72 hours before the first dose of study drug.
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients must agree not to breast feed after the time of consent and for at least 6 months after the administration of the last dose of study drug.
- Male people
- Male patient who has had a successful vasectomy (confirmed azoospermia)
- Male patient agrees to use effective contraception, including condom use, from screening until at least 3 months after the last dose of study drug (no sperm donation is allowed during the study period and for at least 3...
- Male patient with a female partner who is a WOCBP and is using a highly efficient method of contraception as described above
What rules you out
- Patients who have received more than 1 prior systemic therapy (i.e., fostrox + lenvatinib or lenvatinib must be administered as second-line treatment)
- Patients who have received first-line systemic therapy for locally advanced unresectable or metastatic HCC other than an IO combination
- Patients who have received a prior TKI (e.g. lenvatinib, regorafenib, cabozantinib etc.) in the IO combination
- Patients with a history of hypersensitivity to lenvatinib or any of its components (active ingredient or excipients)
- Patients with fibrolamellar HCC, sarcomoid HCC, or a mix of HCC and intrahepatic cholangiocarcinoma (iCCA)
- Patients with central nervous system metastasis
- Patients with VP4 portal vein tumor thrombosis (PVTT)
- Patients with significant cardiovascular disease within 3 months prior to randomization
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Unstable angina
- Myocardial infarction
- Cardiac arrhythmia associated with hemodynamic instability
- people with Corrected QT interval (QTcF) \>470 msec at Screening (corrected by Fridericia Formula)
- Patients with prior allogeneic stem cell or solid organ transplantation
- Patients with systemic infection requiring treatment including active tuberculosis within 14 days prior to the first dose of study drug (prophylactic oral antibiotics are permitted)
- Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study
- Patients with active malignancy within the past 36 months prior to randomization (except for completed resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in-situ, intramucosal carcinoma...
- Patients with gastric or esophageal varices that require treatment treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (e.g. nonselective beta-blocker) is permitted.
- Patients with bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring (e.g. warfarin etc.). Treatment with low molecular weight heparin and factor X inhibitors which do not require...
- Systolic blood pressure (BP) \>160 mmHg or diastolic BP \>100 mmHg despite optimal antihypertensive therapy, or uncontrolled without changes in antihypertensive agents within 1 week prior to screening
- Clinical ascites regardless of the severity (mild, moderate, or severe). Radiological ascites managed with diuretics and a low-sodium diet are accepted if the Child-Pugh score is A.
- History of encephalopathy within the 6 months prior to randomization or current hepatic encephalopathy
- Receiving drugs that are extensively metabolized by CYP3A4 that have a narrow therapeutic index must be discontinued 5 half-lives before the first dose of study drug (fostrox). Information on CYP3A4 was referenced from...
- CredibleMeds (https://crediblemeds.org)
- DrugBank (https://go.drugbank.com/categories/DBCAT002646)
- Receiving drugs that are strong inhibitors of P-glycoprotein (P-gP) and/or breast cancer resistance protein (BCRP)
- Proteinuria as defined by urine protein ≥1 g/24 hours at screening. Patients having \>2+ proteinuria on urine dipstick testing will undergo a 24 hour urine collection or urine protein-to-creatinine ratio (UPCR) test for...
- Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment
- Receiving anticancer therapy for HCC within 4 weeks prior to the first dose of study drug (fostrox)
- Receiving any other investigational agent within 4 weeks prior to screening
- Enrolled in another clinical study with an investigational drug
- Are unable to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study drug
- Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient's safety, as per the investigator's judgment
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.