Status:
UNKNOWN
To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatocellular Carcinoma
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Currently the available first line palliative therapy for advanced HCC is Sorafenib and Lenvatinib of which Lenvatinib is tolerated better. Unfortunately, patients tend to progress after few months of...
Detailed Description
(A) STUDY HYPOTHESIS * Mebendazole augments response of lenvatinib by synergistic response. * Addition of anti angiogenic drugs (lenvatinib and mebendazole) to hypoxic environment generated post loco...
Eligibility Criteria
Inclusion
- Cirrhosis of Liver with HCC on imaging and/or biopsy or cytology
- Child Pugh A, Child Pugh B \< 8
- Advanced HCC - as defined by BCLC - C
- ECOG Performance Status 1-2
- Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at screening and no change in antihypertensive therapy within 1 week prior to commencement of intervention.
- Valid Consent
- Age 18-70 years
Exclusion
- Decompensated Cirrhosis
- Child Pugh C, Child Pugh B \> 7
- HCC patients with a curative therapy (RFA/MWA or LT)
- Prior systemic therapies (or) immunotherapy for HCC
- ECOG Performance Status 3-4
- Post Liver transplant HCC recurrence
- Pregnancy
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 19 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04443049
Start Date
July 10 2020
End Date
June 19 2022
Last Update
October 5 2021
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070