Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC
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|ClinicalTrials.gov Identifier: NCT04241523|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Drug: Lenvatinib 4 mg Oral||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Lenvatinib as a Conversion Therapy in Patients With Potentially Resectable Hepatocellular Carcinoma: A Single-Arm and Open-Label Prospective Study|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||February 2022|
The patients will receive lenvatinib treatment and will be evaluated for the feasibility of liver resection every 8 weeks. For those who underwent liver resection, they will receive lenvatinib treatment for another 48 weeks. In case of tumor recurrence, intolerance, death, or need for other antitumor treatment, the treatment shall be stopped.
Drug: Lenvatinib 4 mg Oral
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.
Other Name: Lenvima 4 mg Oral
- Resection rate [ Time Frame: 1 year after LPI ]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).
- Overall survival (OS) [ Time Frame: 3 years ]The duration from the date of recruitment to the date of death from any cause.
- Objective response rate (ORR) [ Time Frame: 1 year after LPI ]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)
- Serum Biomarkers [ Time Frame: 1 year after LPI ]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.
- Adverse events(AE) and Serious adverse events(SAE) [ Time Frame: 1 year after LPI ]
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.
- Health-related quality of life: EORTC QLQ-HCC18 [ Time Frame: 1 year after LPI ]Health-related quality of life questionnaire measured by EORTC QLQ-HCC18.
- Exploratory serum biomarker research [ Time Frame: 1 year after LPI ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241523
|Contact: Jian Zhoufirstname.lastname@example.org|
|Contact: Huichuan Sunemail@example.com|
|Anhui Provincial Hospital||Recruiting|
|Hefei, Anhui, China, 230000|
|Contact: Lianxin Liu|
|Contact: Weidong Jia|
|Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430000|
|Contact: Zhiyong Huang|
|West China Hospital||Recruiting|
|Chengdu, Sichuan, China, 610000|
|Contact: Tianfu Wen|
|180 Fenglin Road||Recruiting|
|Shanghai, China, 200032|
|Contact: Jian Zhou 0086-21-64041990 firstname.lastname@example.org|
|Contact: Huichuan Sun 0086-21-64041990 email@example.com|
|Principal Investigator: Jian Zhou|
|Principal Investigator: Huichuan Sun|
|Principal Investigator:||Jian Zhou||Shanghai Zhongshan Hospital|