Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Lenvatinib 4 mg Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT04241523

HCC-LEN-Conversion

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Lenvatinib 4 mg Oral