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Hepatocellular Carcinoma (HCC)Phase 2NCT06762782

Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery

A Phase 2 study testing Postoperative adjuvant lenvatinib and Supportive care measures in people with Hepatocellular Carcinoma (HCC) and Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) At High Risk of Recurrence After Curative Resection or Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, randomized, controlled, open, phase II, multicenter clinical study, which aims to evaluate the efficacy and safety of lenvatinib for adjuvant treatment of high-risk recurrent liver cancer after radical surgery. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Postoperative adjuvant lenvatinib and Supportive care measures
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteChina
Study dates
Feb 2025to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Certainly, here is the translation of the provided text into English:
  • Age between 18 to 80 years old, gender not limited;
  • Received radical treatment surgery for liver cancer within 4 to 8 weeks prior to enrollment, and meet the following criteria: (1) Intraoperative judgment criteria: ① No gross tumor thrombus in the hepatic vein, portal vein, bile duct, and inferior vena cava; ② No invasion of adjacent organs, no hepatic hilum lymph nodes or distant metastasis; ③ The liver resection margin is ≥1cm from the tumor border; if the margin is less than 1cm, the histological examination of the resected liver surface shows no residual tumor cells, i.e., negative resection margin. (2) Postoperative judgment criteria: ① Ultrasound, computed tomography(CT), magnetic resonance imaging(MRI) examinations (at least two of these) are performed within 1 to 2 months after surgery, with no residual or recurrent tumor lesions in radical resection cases, and no active tumor lesions in radical ablation cases; ② If serum alpha-fetoprotein(AFP), des-gamma-carboxy prothrombin(DCP), and a combination of 7 Micro ribonucleic acid(microRNAs) and other tumor markers were elevated before surgery, then quantitative measurement of tumor markers is required 8 weeks after surgery, and their levels drop to the normal range; if serum alpha-fetoprotein(AFP) does not return to normal within 8 weeks after surgery , will not be included.
  • Postoperative pathological examination confirms hepatocellular carcinoma(HCC), and all tumor nodules are completely removed with negative resection margins.
  • Imaging examinations ≥4 weeks after surgery confirm no recurrence or metastasis.
  • Expected survival >3 months;
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  • hepatitis B virus(HBV) deoxyribonucleic acid(DNA) <10^4 copies/ml (2000 IU/ml), if hepatitis B virus(HBV) deoxyribonucleic acid(DNA) ≥10^4 copies/ml, antiviral treatment should be initiated first until hepatitis B virus(HBV) deoxyribonucleic acid(DNA) is reduced to below 10^4 copies/ml before entering the study, and continue to take antiviral medication and monitor liver function and hepatitis B virus(HBV) load.
  • At least one of the following high recurrence risk factors exists:
  • <!-- -->
  • Tumor diameter >5cm
  • Multiple lesions (>3)
  • Pathology indicates MVI positivity
  • Edmondson III-IV grade
  • Persistently abnormal alpha-fetoprotein 8. No history of other tumors, and no antitumor treatment before surgery; 9. Eastern Cooperative Oncology Group(ECOG) score: 0-1. 10. Major organ functions are normal, i.e., meeting the following criteria:
  • Hematology examination (within 14 days before screening, without blood transfusion or use of granulocyte colony stimulating factor(G-CSF)):
  • Hemoglobin ≥90 g/L;
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L;
  • Platelet count ≥75×10^9/L;
  • Biochemical examination (within 14 days before screening, without the use of albumin):
  • Albumin ≥28 g/L;
  • Total bilirubin ≤1.5×upper limit of normal (ULN);
  • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤3×ULN;
  • Creatinine ≤1.5×ULN;
  • Coagulation function:
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
  • Activated partial thromboplastin time (APTT) ≤1.5×ULN. 11.Patients with reproductive capacity, both male and female, must use reliable contraceptive measures during the study medication use and for 60 days after the last dose.

Who cannot join

  • Here is the translation of the provided text into English:
  • Pathologically diagnosed as a mixed type of hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC).
  • Positive surgical margins or tumor rupture.
  • Reoperation for recurrent liver cancer.
  • History of other malignancies within 5 years, unless the patient has undergone potentially curative treatment and has no evidence of the disease for 5 years, except for patients who have successfully undergone resection surgery for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ (the 5-year requirement does not apply).
  • Past or current congenital or acquired immunodeficiency diseases.
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  • Patients who have undergone allogeneic transplantation.
  • Insufficient biopsy and/or surgical samples are unavailable.
  • Pregnant and breastfeeding patients.
  • Received targeted drug therapy such as sorafenib, lenvatinib, regorafenib, or immunomodulatory therapy such as anti-PD-1, anti-PD-L1, anti-CTLA-4 before surgery.
  • Unable to provide informed consent (due to language, intellectual capacity, etc.).
  • Active bleeding or coagulation abnormalities, with a tendency to bleed or currently undergoing thrombolytic, anticoagulant, or antiplatelet therapy.
  • History of gastrointestinal bleeding within the past 4 weeks or a clear tendency towards gastrointestinal bleeding (e.g., known active local ulcer lesions, fecal occult blood ++ or more, if persistent fecal occult blood +, gastroscopy should be performed), or other conditions that may cause gastrointestinal bleeding as determined by the investigator (e.g., severe gastric fundus/esophageal varices).
  • Significant clinically meaningful cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months, congestive heart failure (New York Heart Association NYHA class >2), arrhythmias that are poorly controlled or require pacemaker treatment, uncontrolled hypertension with medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg).
  • Allergy to chemotherapy drugs or contraindications to surgery.
  • History of thrombosis or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.
  • History of gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within the past 6 months.
  • Not yet recovered from surgery, such as having unhealed incisions or severe postoperative complications.
  • History of alcohol, psychotropic drugs, or other drug abuse within the past 6 months.
  • Presence of other serious diseases that the investigator deems unsuitable for participation in this study;
  • Currently participating in other therapeutic/interventional clinical trials.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haomin Zhou contact

86-13645165073

hmzhou@njmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Haomin Zhou, 86-13645165073, hmzhou@njmu.edu.cn

    Recruiting

Other trials in China

About this study

This study is a prospective, randomized, controlled, open, phase II, multicenter clinical study, which aims to evaluate the efficacy and safety of lenvatinib for adjuvant treatment of high-risk recurrent liver cancer after radical surgery.

This study is divided into 3 stages: screening period (screening period 28 days), treatment period (up to 12 months, or until any of the following occurs, whichever occurs first: ① The subject has an intolerable toxic reaction and is still not relieved after dose adjustment; ② The subject's first imaging confirmed disease recurrence or withdrew from the study for other reasons), and follow-up period (12 months after the end of treatment).

Read more

Dosage regimen:

Eligible subjects were randomly assigned to the experimental group or the control group in a 2:1 ratio, with surgical method (radical surgery vs ablation) as the stratification factor. The experimental group received lenvatinib treatment, and the control group received best supportive care

Being tested
Postoperative adjuvant lenvatinib, Supportive care measures
Keywords
lenvatinib；adjuvant therapy；hepatocellular carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative adjuvant lenvatinibDrug

    Follow the instructions and take lenvatinib 8 mg (body weight ≤ 60Kg) or 12 mg (body weight ≥ 60Kg) orally once a day.

  • Supportive care measuresOther

    Adjuvant treatments such as antiviral, TACE, HAIC, radiotherapy, and systemic antitumor therapy can be used

Study groups in NCT06762782
Study groupRoleWhat they receive
Treatment groupExperimentalAccording to the instructions, lenvatinib 8mg (weight ≤ 60Kg) or 12mg (weight ≥ 60Kg) was given orally once a day, and active monitoring was performed.
Receives: Drug: Postoperative adjuvant lenvatinib
Control groupOtherAfter surgery, the best supportive care was given, and active monitoring was performed.
Receives: Other: Supportive care measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year cumulative recurrence-free patient percentage

    Proportion of patients with high-risk recurrent hepatocellular carcinoma who are free of tumor recurrence within one year after curative surgery.

    Measured: The patient started taking lenvatinib after radical surgery for hepatocellular carcinoma and continued treatment for up to 1 year.

Secondary outcomes (4)

  1. Recurrence Free Survival

    The time elapsed from the date of enrollment to tumor recurrence or death from any cause (if the subject died before disease recurrence). Surviving subjects without confirmed tumor recurrence at the database cutoff date were censored based on the date of the last imaging tumor assessment. The date of tumor recurrence was the date of the first imaging confirmation of tumor recurrence.

    Measured: The patient started taking lenvatinib after radical surgery for hepatocellular carcinoma and continued treatment for up to 3 years.

  2. Overall Survival

    The elapsed time from the date of enrollment to the date of death from any cause. If the subject was still alive at the database cutoff date, the subject was censored at the date of the last survival follow-up in the database.

    Measured: The time span from the date of surgery to the date of the patient's last follow-up visit or death, assessed up to 3 years.

  3. Time To Recurrence

    The time elapsed from the date of enrollment to the date of tumor recurrence. Subjects who did not experience tumor recurrence at the database cutoff date were censored at the date of last imaging tumor assessment.

    Measured: The time span from the date of radical liver resection to the date of first documented tumor recurrence, assessed up to 3 years.

  4. Diachronic changes in quality of life scores based on FACT-Hep scale

    The FACT-Hep scale is a 46-item, self-assessed, multidimensional, validated questionnaire used to assess health-related quality of life in subjects with liver cancer types. FACT-Hep assessment dimensions include physical status, social/family status, emotional status, functional status and additional symptoms of hepatocellular carcinoma. Subjects responded to each item on the scale on a scale from 0 (not at all) to 4 (extremely). The average time required to complete the questionnaire is less than 10 minutes. Five subscale scores and one overall score can be calculated.

    Measured: From enrollment date to database deadline, assessed up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible subjects were randomly assigned to the experimental group or the control group at a ratio of 2:1, with surgical method (radical surgery vs ablation) as the stratification factor. Treatment group: According to the instructions, lenvatinib 8mg (weight ≤ 60Kg) or 12mg (weight ≥ 60Kg) was given orally once a day, and active monitoring was performed. Control group: After surgery, the best supportive care was given, and active monitoring was performed.
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06762782
Sponsor's protocol ID
2024-SR-708
Status last verified
Dec 2024
First submitted
22 Dec 2024
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Involving patient privacy and biometric information security

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Postoperative adjuvant lenvatinib and Supportive care measures in people with Hepatocellular Carcinoma (HCC) and Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) At High Risk of Recurrence After Curative Resection or Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haomin Zhou (86-13645165073, hmzhou@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year cumulative recurrence-free patient percentage (time frame: The patient started taking lenvatinib after radical surgery for hepatocellular carcinoma and continued treatment for up to 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06762782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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