Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to assess efficacy and safety of lenvatinib as a preoperative conversion therapy in patients with potentially resectable HCC. Investigator hypothesized that lenvatinib may be an effective conversion treatment for HCC, and preoperative treatment with lenvatinib can improve resectability in patients with potential resectable HCC and improve the long term survival.
For patients with potentially resectable HCC (intermediate or advanced stage), upfront therapy with surgical resection is of high recurrence rate after surgery. The aim of the single-arm, open-label, prospective phase II clinical trial is to evaluate whether preoperative lenvatinib treatment could improve resectability and therefore improve the long term survival. Participants who are recruited in this study in this study will be treated with lenvatinib and will be evaluated for the feasibility for surgical resection by a multidisciplinary team every 8 weeks. If the participants underwent curative resection, they will receive lenvatinib treatment for 48 weeks after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Planned doses of 8 mg of lenvatinib per day for patients with body weight \<60 kg, and 12 mg for those with body weight ≥60 kg. In case of treatment-related adverse effects, interruption or reduction is allowed.
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGTongji Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITINGResection rate
The percentage of patients who receive curative liver resection for HCC. The criteria for curative resection: (1) no active tumor thrombosis is observed in hepatic veins, portal veins, bile ducts or inferior vena cava; or the type of portal vein invasion was converted from Vp3/Vp4 to Vp1/Vp2; (2) no active metastasis to adjacent organs or distant organs, or to lymph nodes; (3) the surgical margin ≥ 0.5 cm; (4) the number of active tumor nodules decreases from ≥4 to \<4; (5) the ratio of future liver volume to standard liver volume increases from \<40% to ≥40% (for those with liver cirrhosis) or from \<30% to ≥30% (for those without liver cirrhosis).
Time frame: 1 year after LPI
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Time frame: 3 years
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)
Time frame: 1 year after LPI
Serum Biomarkers
To explore the relationship between the baseline level and dynamic changes of serum markers(AFP and PIVKA-II) and therapeutic response, Peripheral blood serum was collected at baseline and at each follow-up visit.
Time frame: 1 year after LPI
Adverse events(AE) and Serious adverse events(SAE)
An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) refers to an event in clinical trials that requires inpatient hospitalization or causes prolongation of existing hospitalization, permanent disability, incapacity, threats to life or death, and birth defect, etc. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.
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180 Fenglin Road
Shanghai, China
RECRUITINGTime frame: 1 year after LPI
Health-related quality of life: EORTC QLQ-HCC18
Health-related quality of life questionnaire measured by EORTC QLQ-HCC18.
Time frame: 1 year after LPI
Exploratory serum biomarker research
About 10 mL peripheral blood will be collected at baseline and at each follow-up visit. The correlations between serum biomarkers at baseline or the dynamic changes and treatment response will be analyzed.
Time frame: 1 year after LPI