Actively Recruiting
Study of Lenvatinib as Additional Treatment for Patients with High-Risk Liver Cancer Recurrence After Surgery A Randomized Clinical Trial Comparing Lenvatinib and Supportive Care
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-01-08
276
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
T
The First People's Hospital of Changzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of lenvatinib as an additional treatment to prevent recurrence in patients with high-risk liver cancer (hepatocellular carcinoma) after they have undergone radical surgery. This phase II, multicenter, randomized controlled study aims to compare lenvatinib with best supportive care in these patients, focusing on their recurrence-free survival over one year. Participants are randomly assigned in a 2:1 ratio to either receive lenvatinib orally once daily, with doses adjusted based on body weight (8 mg for 60 kg or less, 12 mg for more than 60 kg), or to receive best supportive care that may include treatments like antiviral therapy, TACE, HAIC, radiotherapy, or systemic antitumor therapies. The study includes a screening period of 28 days, followed by up to 12 months of treatment or until intolerable side effects, disease recurrence detected by imaging, or withdrawal. After treatment, participants enter a 12-month follow-up period to monitor outcomes. Throughout the study, patients have imaging scans such as ultrasound, CT, or MRI to check for tumor recurrence and regular blood tests to assess tumor markers and liver function. Safety is closely monitored, and participants must meet strict criteria including normal organ function and controlled hepatitis B virus levels. The main outcome measured is the percentage of patients who remain free of cancer recurrence one year after starting lenvatinib following surgery.
CONDITIONS
Official Title
Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 to 80 years old
- Underwent radical surgery or ablation for liver cancer within 4 to 8 weeks before enrollment
- No gross tumor thrombus in major veins or bile duct, no adjacent organ invasion or metastasis
- Liver resection margin at least 1 cm from tumor or negative tumor cells if less than 1 cm
- Imaging within 1 to 2 months after surgery shows no residual or recurrent tumor
- Tumor markers (AFP, DCP, microRNAs) elevated before surgery return to normal within 8 weeks after surgery
- Postoperative pathology confirms hepatocellular carcinoma with complete tumor removal and negative margins
- Imaging 4 weeks after surgery confirms no recurrence or metastasis
- Expected survival longer than 3 months
- Hepatitis B virus DNA less than 10^4 copies/ml or controlled with antiviral treatment
- At least one high-risk factor: tumor diameter over 5 cm, more than 3 lesions, microvascular invasion positive, Edmondson grade III-IV, or persistently abnormal AFP
- No history of other tumors and no antitumor treatment before surgery
- ECOG performance status 0-1
- Normal major organ functions including blood counts, liver and kidney function, and coagulation within specified limits
- Use of reliable contraception during treatment and for 60 days after last dose for patients with reproductive capacity
You will not qualify if you...
- Mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma diagnosis
- Positive surgical margins or tumor rupture
- Reoperation for recurrent liver cancer
- Other malignancies within past 5 years except some treated skin and bladder cancers
- Congenital or acquired immunodeficiency
- Previous allogeneic transplantation
- Insufficient biopsy or surgical samples
- Pregnant or breastfeeding
- Prior targeted or immunotherapy before surgery
- Unable to give informed consent
- Active bleeding or coagulation disorders, or on blood thinning therapies
- Recent gastrointestinal bleeding or high risk of bleeding
- Significant cardiovascular disease in past 6 months
- Allergy to chemotherapy drugs or contraindications to surgery
- Recent thrombosis or thromboembolic events
- Recent gastrointestinal perforation or abdominal infections
- Unhealed surgery wounds or severe postoperative complications
- History of substance abuse within past 6 months
- Other serious diseases deemed unsuitable by investigators
- Participation in other interventional clinical trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
H
Haomin Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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