Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC

NCT04241523 | Unknown Phase 2

• 1 other identifier: HCC-LEN-Conversion
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Resection 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).

  1 year after LPI

Secondary Outcomes (6)

• Overall survival (OS)

  3 years

• Objective response rate (ORR)

  1 year after LPI

• Serum Biomarkers

  1 year after LPI

• Adverse events(AE) and Serious adverse events(SAE)

  1 year after LPI

• Health-related quality of life: EORTC QLQ-HCC18

  1 year after LPI

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Lenvatinib 4 mg Oral 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.

Also known as: Lenvima 4 mg Oral

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75;
• The participant must have confirmed diagnosis of HCC histologically or clinically;
• The participant must have at least one untreated intrahepatic lesion that can be evaluated by contrast-enhanced CT or MRI;
• 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;
• ECOG PS 0-1 and Child-Pugh A;
• Surgical resection is not the first choice according to MDT evaluation;
• Written informed consent;

You may not qualify if:

• WBC\<4.0\*10\^9/L, HB\<80 g/L, PLT\<75\*10\^9/L and NEUT\<1.5×10\^9/L;
• Coagulation function: (prothrombin time) international normalized ratio (INR) \>1.2;
• 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);
• Lymph node metastasis to hilar of lung or liver, or peripheral tissue adhesion;
• Participated in other clinical trials 30 days before enrollment;
• With ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis;
• Suspected allergy to study drug;
• With other organ dysfunction, it is not expected to be tolerated general anesthesia or hepatectomy;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Tongji Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• West China Hospital: collaborator

Study Sites (4)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian Zhou

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou

CONTACT

0086-21-64041990; zhou.jian@zs-hospital.sh.cn

Huichuan Sun

CONTACT

0086-21-64041990; sun.huichuan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: February 1, 2022
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)