50 Participants Needed

Lenvatinib + TACE for Liver Cancer

DC
SW
Overseen ByShondra Word
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
Must be taking: Antivirals
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have hepatitis B or C, you must continue antiviral therapy while on the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Lenvatinib + TACE for liver cancer?

Research suggests that combining Lenvatinib with TACE may improve outcomes for patients with liver cancer by reducing tumor growth and recurrence. Lenvatinib helps block the growth of new blood vessels that tumors need to grow, especially after TACE, which cuts off the tumor's blood supply.12345

Is the combination of Lenvatinib and TACE safe for treating liver cancer?

The combination of Lenvatinib and TACE has been studied for safety in treating advanced liver cancer. Lenvatinib, used in various cancers, can cause side effects like high blood pressure, diarrhea, tiredness, and weight loss, which need careful management. These side effects are common with treatments targeting blood vessel growth in tumors.14678

How is the treatment Lenvatinib + TACE different from other treatments for liver cancer?

Lenvatinib + TACE is unique because it combines a drug (lenvatinib) that blocks blood vessel growth in tumors with a procedure (TACE) that delivers chemotherapy directly to the liver tumor, potentially improving outcomes by reducing tumor growth and recurrence.236910

What is the purpose of this trial?

This study will examine the effects of a six-month regimen of neoadjuvant lenvatinib in combination with transcatheter arterial chemoembolization (TACE) prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria. Clinical, outcomes, and exploratory data will be compared to a matched, retrospective cohort.

Research Team

Dr. Maen Abdelrahim - Oncologist in ...

Maen Abdelrahim, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

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.
I am an adult with liver cancer that has progressed beyond early stages.
See 8 more

Exclusion Criteria

I am not pregnant, breastfeeding, allergic to lenvatinib, and I agree to use contraception.
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.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Neoadjuvant Treatment

Participants receive a six-month regimen of lenvatinib in combination with TACE prior to liver transplantation

6 months
Monthly visits for TACE and lenvatinib administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months
Monthly visits for monitoring

Transplantation and Post-Transplant Follow-up

Participants undergo liver transplantation and are monitored for outcomes such as tumor necrosis and survival

Long-term

Treatment Details

Interventions

  • Lenvatinib
  • Transcatheter Arterial Chemoembolization
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Eisai Inc.

Industry Sponsor

Trials
524
Recruited
161,000+
Founded
Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.
Headquarters
Woodcliff Lake, NJ, USA
Known For
Neurology and Oncology
Top Products
Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)
Lynn Kramer profile image

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno profile image

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

Lenvatinib is an effective multikinase inhibitor approved for treating radioiodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma, showing favorable efficacy in various malignancies.
While lenvatinib has beneficial effects, it is associated with common adverse events like hypertension and fatigue, necessitating careful monitoring and management to enhance patient quality of life and treatment adherence.
Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer.Cabanillas, ME., Takahashi, S.[2019]
In a study of 247 patients with unresectable hepatocellular carcinoma, LEN-TACE sequential therapy showed significantly better overall survival and progression-free survival compared to LEN monotherapy, indicating its enhanced efficacy.
The objective response rate for LEN-TACE was 61.9%, and the study found that a positive initial response to LEN treatment was a key factor in achieving a deep response during sequential therapy, suggesting that prior treatment response can guide future treatment strategies.
Objective Response by mRECIST to Initial Lenvatinib Therapy Is an Independent Factor Contributing to Deep Response in Hepatocellular Carcinoma Treated with Lenvatinib-Transcatheter Arterial Chemoembolization Sequential Therapy.Kuroda, H., Oikawa, T., Ninomiya, M., et al.[2022]

References

Comparison of efficacy and safety between transarterial chemoembolization (TACE) combined with lenvatinib versus TACE combined with sorafenib in the treatment of intermediate and advanced hepatocellular carcinoma. [2023]
Impact of combining Lenvatinib with Transarterial chemoembolization for unresectable hepatocellular carcinoma. [2023]
Efficacy and safety of transcatheter arterial chemoembolization-lenvatinib sequential therapy for patients with unresectable hepatocellular carcinoma: a single-arm clinical study. [2022]
Safety and Efficacy of TACE + Lenvatinib in Treating Advanced Hepatocellular Carcinoma: A Systematic Review and Meta- analysis. [2023]
Effect of bevacizumab administered prior to transarterial chemoembolization on the therapeutic effects of lenvatinib given post-TACE in primary liver cancer patients. [2023]
Transarterial chemoembolization plus lenvatinib versus transarterial chemoembolization plus sorafenib as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A prospective randomized study. [2022]
Efficacy and safety of transarterial chemoembolization plus lenvatinib in the treatment of advanced hepatocellular carcinoma: A meta-analysis. [2023]
Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. [2019]
Objective Response by mRECIST to Initial Lenvatinib Therapy Is an Independent Factor Contributing to Deep Response in Hepatocellular Carcinoma Treated with Lenvatinib-Transcatheter Arterial Chemoembolization Sequential Therapy. [2022]
Efficacy and Safety of Lenvatinib-Transcatheter Arterial Chemoembolization Sequential Therapy for Patients with Intermediate-Stage Hepatocellular Carcinoma. [2021]
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