Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma

NCT04227808

Hepatocellular Carcinoma (HCC)

UNKNOWN PHASE2

Lenvatinib Following Liver Transplantation in Patients With High-Risk Hepatocellular Carcinoma

NCT04168944

Hepatocellular Carcinoma

UNKNOWN PHASE2/PHASE3

Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

NCT04642547

Hepatocellular Carcinoma Molecular Targeted Therapy

COMPLETED NA

A Study to Assess the Safety and Efficacy of Lenvatinib as First-line Treatment in Participants With Unresectable HCC

NCT04297254

Carcinoma, Hepatocellular

COMPLETED PHASE4

Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation

NCT04415567

Hepatocellular Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma (HCC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

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.

Group Type EXPERIMENTAL

Lenvatinib 4 mg Oral

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lenvima 4 mg Oral

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female aged 18-75;
2. The participant must have confirmed diagnosis of HCC histologically or clinically;
3. The participant must have at least one untreated intrahepatic lesion that can be evaluated by contrast-enhanced CT or MRI;
4. The BCLC stage B/C patients, more than 3 tumor nodes or have portal vein tumor thrombus (Vp3-Vp4 according to LCSGJ PVTT classification) or extrahepatic metastases limited to one organ and the number of metastases nodules is no more than 3;
5. ECOG PS 0-1 and Child-Pugh A;
6. Surgical resection is not the first choice according to MDT evaluation;
7. Written informed consent;

Exclusion Criteria

1. WBC\<4.0\*10\^9/L, HB\<80 g/L, PLT\<75\*10\^9/L and NEUT\<1.5×10\^9/L;
2. Coagulation function: (prothrombin time) international normalized ratio (INR) \>1.2;
3. Liver function: serum albumin (ALB)\<3.5 g/dl, total bilirubin (TBIL)\>1.5 times the upper limit of normal range, alanine aminotransferase and aspartate aminotransferase (ALT and AST)\>3 times the upper limit of normal range; renal function index: serum creatinine (CRE)\>1.5 times the upper limit of normal range; uncontrolled hypertension (\>150/90mm Hg);
4. Lymph node metastasis to hilar of lung or liver, or peripheral tissue adhesion;
5. Participated in other clinical trials 30 days before enrollment;
6. With ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis;
7. Suspected allergy to study drug;
8. With other organ dysfunction, it is not expected to be tolerated general anesthesia or hepatectomy;
9. Other conditions that the investigators considered not unsuitable for inclusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No