NCT05444478

Brief Summary

This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
14mo left

Started Jul 2022

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2022Jul 2027

First Submitted

Initial submission to the registry

June 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

June 29, 2022

Last Update Submit

November 5, 2023

Conditions

Hepatocellular CarcinomaMicrowave AblationLiver CancerLenvatinibRecurrent Tumor

Outcome Measures

Primary Outcomes (2)

  • Tumor-free survival rate at 36 months

    Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause

    36 months

  • Over-all survival (OS) rate at 36 months

    OS is the length of time from the date of microwave ablation until death from any cause.

    36 months

Secondary Outcomes (2)

  • Adverse events

    24 months

  • Complication rate

    36 months

Study Arms (2)

Microwave ablation

EXPERIMENTAL

Patients only accepted microwave ablation

Procedure: Microwave ablation

Microwave ablation plus lenvatinib

EXPERIMENTAL

Patients accepted microwave ablation plus lenvatinib

Procedure: Microwave ablationDrug: Lenvatinib

Interventions

Microwave ablationPROCEDURE

only microwave ablation for tumor

Microwave ablationMicrowave ablation plus lenvatinib
LenvatinibDRUG

lenvatinib (80 mg for body no more than 60kg，120 mg for body weight \>60 kg)

Microwave ablation plus lenvatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；
  • recurrent HCC without any tumor related therapy；
  • Tumor number ≤3；
  • Tumor size ≤5cm;
  • Good performance, KPS≥90；
  • Age：18-75
  • Child-Pugh A or B（score of the B level is no more than 7）
  • Baseline laboratory examinations meet the Criteria： Leukocyte ≥3.0×109/L； Blood platelet ≥75×109/L； Hemoglobin ≥100g/L； ALT、AST ≤ 3 x limit of normal（ULN）； Serum creatinine ≤ 1.5 x ULN； Prothrombin time \< ULN+4 s；INR \< 1.5, Albumin ≥30g/L ； Total bilirubin ≤34mmol/L；

You may not qualify if:

  • disagreeing to receive follow-up observation and participate the clinical study;
  • Accompanying with a history of other malignancies;
  • Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
  • with extrahepatic metastasis or lymph metastasis;
  • receiving system therapy such as targeted therapy or immunotherapy;
  • receiving local therapy such as ablation or TACE;
  • Any of the following occurred within 12 months of the study: myocardial infarction, severe / unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing arrhythmia by NCI-CTCA standard ≥ 2, prolonged QTc interval (450 ms for males, and\> 470 ms for females;
  • other serious acute, chronic physiological or mental disorders or abnormal laboratory examination may increase the risk of participation in study treatment or may interfere with the interpretation of study findings or whom the investigator considers not fit;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Provincial People's Hospital

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsRecurrence

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xianhai Mao, Professor

    Hunan Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Qunfnag Zhou, MD

CONTACT

86 19868000115zhouqun988509@163.com

Xiaohui Wang, MD

CONTACT

8615692436948xiaohuiwang21@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 6, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

CN(1)