Lenvatinib + TACE for Liver Cancer

Overseen By Shondra Word

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Methodist Hospital Research Institute

Must be taking: Antivirals

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Hypertension, Cardiovascular impairment, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{2 3 6 9 10}

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

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.

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.

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

Group I: Matched Historical Control Patients Experimental Treatment 1 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 Transplantation Experimental Treatment 2 Interventions

Regimen of six months neoadjuvant lenvatinib in combination with TACE prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria.

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

Eisai Inc.

Chief Medical Officer since 2019

MD

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Impact of combining Lenvatinib with Transarterial chemoembolization for unresectable hepatocellular carcinoma. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcatheter arterial chemoembolization-lenvatinib sequential therapy for patients with unresectable hepatocellular carcinoma: a single-arm clinical study. [2022]

4. Romania pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of TACE + Lenvatinib in Treating Advanced Hepatocellular Carcinoma: A Systematic Review and Meta- analysis. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of bevacizumab administered prior to transarterial chemoembolization on the therapeutic effects of lenvatinib given post-TACE in primary liver cancer patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transarterial chemoembolization plus lenvatinib in the treatment of advanced hepatocellular carcinoma: A meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lenvatinib-Transcatheter Arterial Chemoembolization Sequential Therapy for Patients with Intermediate-Stage Hepatocellular Carcinoma. [2021]