Clinical trial NCT04241523: Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: Anhui Provincial Hospital
name: West China Hospital
First posted: 2020-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resection rate
timeFrame: 1 year after LPI
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Objective response rate (ORR)
timeFrame: 1 year after LPI
measure: Serum Biomarkers
timeFrame: 1 year after LPI
measure: Adverse events(AE) and Serious adverse events(SAE)
timeFrame: 1 year after LPI
measure: Health-related quality of life: EORTC QLQ-HCC18
timeFrame: 1 year after LPI
measure: Exploratory serum biomarker research
timeFrame: 1 year after LPI
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Zhou
role: PRINCIPAL_INVESTIGATOR
References: