Actively Recruiting
A Multicenter, Open, One-arm Phase II Study of Lenvatinib Mesylate Capsules in Treating Advanced Bone and Soft Tissue Sarcoma After Chemotherapy Failure
Led by Henan Cancer Hospital · Updated on 2023-08-21
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of lenvatinib mesylate capsules in patients with metastatic or surgically unresectable bone and soft tissue sarcomas who have previously received multi-target tyrosine kinase inhibitor (TKI) therapy and did not respond. This open, one-arm Phase II study enrolls 60 patients to assess progression-free survival and objective response rate over approximately 24 months. Participants receive lenvatinib mesylate capsules orally once daily, with the dose depending on body weight: 8 mg for those weighing 60 kg or less, and 12 mg for those over 60 kg. The medication is taken about half an hour after meals with warm water, aiming for consistent daily timing. This treatment continues throughout the study period as investigators monitor patients. During the study, participants undergo regular assessments including tumor measurements that meet RECIST 1.1 criteria, laboratory tests to monitor organ and bone marrow function, and evaluations of physical status. Side effects and any toxicities from previous treatments are monitored to ensure safety. The research team tracks how long patients live without disease progression and their tumor response, with the total participation lasting up to about two years.
CONDITIONS
Brief Title
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 10 to 70, any gender
- ECOG physical status score of 0-1; up to 2 for subjects with amputation
- Expected survival time of 3 months or more
- Diagnosed with bone or soft tissue sarcomas that are metastatic or locally advanced and not suitable for surgery
- Previously treated with apatinib or anlotinib and experienced no response or progression after more than 3 months
- Measurable lesions meeting RECIST 1.1 criteria
- All acute toxicities from previous therapy resolved to grade 0-1 or meet enrollment criteria by first treatment day
- Adequate organ and bone marrow function as defined by blood counts and biochemical tests
- Urine protein less than 2+ or within specified limits if higher
- Thyroid function within normal limits or corrected
- Female participants of reproductive age must have a negative pregnancy test and agree to use effective contraception during and 3 months after treatment; males with partners of reproductive age must agree to contraception or sterilization
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Received radiotherapy, surgery, chemotherapy, immunotherapy, other investigational drugs, or live attenuated vaccine within 4 weeks before first treatment
- Planned surgery or radiation therapy for sarcoma during the study
- Use of immunosuppressive drugs within 14 days before first treatment, except certain inhaled or low-dose steroids
- Severe infection or fever over 38.5°C within 4 weeks before treatment
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Significant bleeding or clotting events within 3 to 6 months before treatment
- Active heart disease within 6 months, including recent heart attack or severe angina
- Left ventricular ejection fraction below 50% or poorly controlled arrhythmias
- Diagnosis of other malignancies within 3 years, except certain treated skin or cervical cancers
- Known allergy to study drug or its ingredients
- HIV infection, active hepatitis B or C
- Other serious medical conditions judged by investigator to pose safety risks or interfere with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive Lenvatinib mesylate capsules orally once daily, with doses adjusted based on body weight. They take the medicine about half an hour after meals with warm water, maintaining a consistent daily schedule.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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