The primary objective of this study is to evaluate the safety of lenvatinib in HCC.
This is a prospective, multi-center, open-label, single-arm, non-comparative, post-marketing phase IV study. This study will enroll 50 participants with unresectable HCC. Participants will receive lenvatinib for 24 weeks or until disease progression, death, intolerable or unacceptable toxicity, or withdrawal of consent, whichever occurs earlier. All participants will be followed up for an end-of-study (EOS) visit at 4 weeks after the completion of 24 weeks of treatment or after last treatment visit if earlier, as applicable that is end-of-treatment (EOT). Participants who completed 24 weeks of therapy and continue to show clinical benefit will be able to continue to receive lenvatinib (beyond week 24 as necessary) as per Investigator's discretion and based on radiological response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Lenvatinib capsules.
HCG Comprehensive Cancer Care Hospital
Bangalore, Karnataka, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Shatabdi Hospital
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. The severity of all adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grades are: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily life \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); and Grade 5 (Death related to AE).
Time frame: Baseline up to Week 24
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 24
Number of Participants with Grades 1 and 2 Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. The severity of all AEs will be graded according to CTCAE version 4.0. The grades are: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); and Grade 5 (Death related to AE).
Time frame: Baseline up to Week 24
Objective Response Rate (ORR)
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Nashik, Maharashtra, India
Apex Wellness Hospital
Nashik, Maharashtra, India
LMMF's Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Somani Hospital
Jaipur, Rajasthan, India
Meenakshi Mission Hospital
Madurai, Tamil Nadu, India
Apollo Gleneagles Hospital Limited
Kolkata, West Bengal, India
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as the best overall response from the start of study treatment up to Week 24. CR per response evaluation criteria in solid tumor (RECIST) 1.1 is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR per RECIST 1.1 is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From the start of study treatment up to Week 24
Progression-free Survival (PFS)
PFS is defined as the time from the start of treatment until the first occurrence of disease progression (PD) or death, whichever is earlier. PD per RECIST 1.1 is defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Time frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurs first) or up to approximately Week 24
Percentage of Participants Requiring Dose Modifications (Dose Interruptions or Dose Reductions)
Time frame: Baseline up to Week 24
Time to First Dose Reduction
Time frame: Baseline up to Week 24