Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma (NCT06138769) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma
South Korea50 participantsStarted 2023-07-20
Plain-language summary
Although atezolizumab-bevacizumab has been positioned as the standard first-line therapy in unresectable heptocellular carcinoma, eventually most patients progressed on this regimen. Despite of multiple drugs are approved for the management of unresectable hepatocellular carcinoma, only a few trials have been conducted to investigate their efficacy in the second-line setting after the progression on atezolizumab-bevacizumab. Lenvatinib is approved first-line multikinase inhibitor in unresectable hepatocellular carcinoma, but has not yet been investigated as second-line therapy in prospective study. In this single arm phase 2 study, the efficacy and safety of lenvatinib will be investigated for patients who progressed on first-line atezolizumab-bevacizumab.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Diagnosis of HCC according to AASLD guidelines
✓. Disease that is not amenable to a curative treatment (e.g. surgery, transplant, radiofrequency ablation)
✓. Prior treatment with atezolizumab plus bevacizumab as first-line treatment for unresectable HCC
✓. Progression after atezolizumab plus bevacizumab, the duration of these treatments must be 2 consecutive treatment cycles or more.
✓. At least 1 RECIST v1.1 measurable untreated lesion
✓. Recovery to ≤ Grade 1 from toxicities related to any prior treatments, unless the adverse events are clinically non-significant and/or stable on supportive therapy
✓. Life expectancy of 12 weeks or longer
✓. Age ≥ 19 years old
Exclusion criteria
✕. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
✕. Prior systemic treatment for HCC, except for atezolizumab plus bevacizumab (i.e. lenvatinib must be second-line systemic treatment)
✕. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
✕. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
✕. Major surgery within 2 months before randomization. Complete healing from major surgery must have occurred 1 month before randomization. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before registration. Subjects with clinically relevant co d. Cavitating pulmonary lesion(s) or endobronchial disease
✕. Moderate or severe ascites (Radiologically detected but clinically insignificant ascites is allowed)
✕. Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 21 days of registration