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Lenvatinib + TACE for Liver Cancer
Phase 2
Waitlist Available
Led By Maen Abdelrahim, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and marrow function criteria must be met
Adults (≥18 years old) with histologically or cytologically confirmed HCC beyond Milan Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of first dose of lenvatinib; 1, 2, 3, 4, 5, 6, 7, 8 months after first dose
Awards & highlights
Study Summary
This trial will study if adding the drug lenvatinib to transcatheter arterial chemoembolization (TACE) before liver transplantation will improve outcomes in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria.
Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had previous cancer treatments, are on the liver transplant list, and can perform daily activities with little to no assistance. They must have well-managed hepatitis if present, good organ function, not be pregnant or breastfeeding, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests a combination of Lenvatinib medication and TACE procedure over six months before a liver transplant in patients with large HCC tumors. It aims to compare these patients' outcomes against those from past records who didn't receive this treatment.See study design
What are the potential side effects?
Lenvatinib may cause high blood pressure, fatigue, loss of appetite, weight loss, nausea, diarrhea or constipation. The TACE procedure could lead to abdominal pain, fever or infection. Both interventions carry risks like bleeding or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs and bone marrow are functioning well.
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I am an adult with liver cancer that has progressed beyond early stages.
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I have not received any treatments and am eligible for a TACE procedure.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take pills by mouth.
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I am on antiviral therapy for my hepatitis B to control the virus.
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I am on the liver transplant list and do not need any other organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at eligibility screening; within 14 days prior to the administration of the first dose of lenvatinib; at time of administration of first dose of lenvatinib; 1, 2, 3, 4, 5, 6, 7, 8 months after first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at eligibility screening; within 14 days prior to the administration of the first dose of lenvatinib; at time of administration of first dose of lenvatinib; 1, 2, 3, 4, 5, 6, 7, 8 months after first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Tumor Necrosis
Secondary outcome measures
Adverse Event Occurrence
Explant Biomarkers
Microvessel Density
+3 moreSide effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155470%
Diarrhoea
69%
Hypertension
57%
Decreased appetite
54%
Weight decreased
49%
Nausea
44%
Fatigue
40%
Headache
38%
Proteinuria
38%
Vomiting
38%
Stomatitis
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Arthralgia
33%
Dysphonia
32%
Constipation
30%
Cough
26%
Asthenia
25%
Oedema peripheral
21%
Rash
20%
Back pain
20%
Myalgia
19%
Abdominal pain
18%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Oral pain
10%
Thrombocytopenia
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Hyponatraemia
7%
Ejection fraction decreased
7%
Haematuria
7%
Malaise
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
7%
Pruritus
6%
Influenza
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Dysuria
5%
Paraesthesia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Malignant pleural effusion
2%
Spinal cord compression
2%
Acute kidney injury
1%
Acute coronary syndrome
1%
Blood uric acid increased
1%
Death
1%
Hypercalcaemia
1%
Monoparesis
1%
Small intestinal obstruction
1%
Intestinal obstruction
1%
Osteoarthritis
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Hepatic failure
1%
Liver injury
1%
Diverticulitis
1%
Appendicitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Intracranial tumour haemorrhage
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
OOL, Treatment Period: Lenvatinib 24 mg
Trial Design
2Treatment groups
Experimental Treatment
Group I: Matched Historical Control PatientsExperimental Treatment1 Intervention
Historical controls will be liver transplant recipients matched on age, etiology of liver disease (viral vs. non-viral), listing tumor size, and number of TACE procedures to cases in the intervention group who receive a transplant.
Group II: Lenvatinib in Combination with TACE Prior to Liver TransplantationExperimental Treatment2 Interventions
Regimen of six months neoadjuvant lenvatinib in combination with TACE prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,325 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,970 Total Patients Enrolled
2 Trials studying Liver Cancer
191 Patients Enrolled for Liver Cancer
Maen Abdelrahim, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, allergic to lenvatinib, and I agree to use contraception.My organs and bone marrow are functioning well.I am a man who can father children and will use condoms or other effective birth control.My high blood pressure is not controlled despite taking medication.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I have had chemotherapy or immunotherapy for liver cancer.My liver function is moderately to severely impaired.I am an adult with liver cancer that has progressed beyond early stages.I have a serious heart condition.I have not received any treatments and am eligible for a TACE procedure.I have had cancer before, but it was a type that is allowed in this study.My liver cancer fits within specific size and number limits.I am fully active or restricted in physically strenuous activity but can do light work.I can take pills by mouth.I am on antiviral therapy for my hepatitis B to control the virus.I have a blood clot in the liver's vein that prevents a specific liver cancer treatment.I am on the liver transplant list and do not need any other organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Matched Historical Control Patients
- Group 2: Lenvatinib in Combination with TACE Prior to Liver Transplantation
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for individuals to become involved in this experiment?
"At this time, no further recruitment is being conducted for the clinical trial. It was originally posted on 20th June 2022 and last updated 15th September 2022. If you are searching for other studies related to liver carcinoma, there are 2604 trials accepting patients at present; Lenvatinib has 148 active medical trials open as well."
Answered by AI
Is this the pioneering research of its kind?
"At present, there are 148 active Lenvatinib trials occurring in 53 countries and 1017 different cities. The initial trial for this drug was conducted back in 2016 by Merck Sharp & Dohme Corp., who recruited 576 participants to complete Phase 1 of the approval process. Since then, 54 studies have concluded their research."
Answered by AI
What is the scope of subjects involved with this clinical investigation?
"Unfortunately this trial is no longer looking for enrollees. It was posted on June 20th 2022 and last revised on September 15th of the same year. Alternatively, there are 2604 trials that accept patients with liver carcinoma and 148 clinical studies offering Lenvatinib treatments both actively recruiting participants presently."
Answered by AI
Can you provide a summary of the past research conducted on Lenvatinib?
"Currently, 148 active clinical trials are investigating the efficacy of Lenvatinib with 32 studies in their final phase. The majority of sites conducting such research are located in Iowa City, IA but numerous other locations across America have joined this effort as well."
Answered by AI
Has the Lenvatinib drug been officially sanctioned by the Food and Drug Administration?
"Due to the lack of evidence regarding efficacy, lenvatinib was assigned a safety rating of 2 on our company's scale. However, there is some supporting data related to its level of risk."
Answered by AI
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