Actively Recruiting
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
Led by Henan Cancer Hospital · Updated on 2023-08-21
60
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.
CONDITIONS
Official Title
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 70 years, male or female
- Eastern Collaborative Oncology Group (ECOG) physical status score of 0-1, or up to 2 if the subject has had an amputation
- Expected survival time of at least 3 months
- Diagnosis of bone or soft tissue sarcomas with distant metastases or locally advanced disease unsuitable for surgery
- Previous treatment with apatinib or anlotinib, with evaluated response as CR, PR, SD, or PD, and progression after other systemic therapies or reprogression after more than 3 months
- Presence of measurable lesions meeting RECIST1.1 criteria
- All acute toxicities from prior therapy or surgery resolved to grade 0-1, except non-safety risk toxicities such as hair loss
- Adequate organ and bone marrow function as defined by specific blood counts and biochemical tests
- Urine protein less than 2+; if 2+ or more, 24-hour urine protein less than or equal to 1g
- Thyroid function within normal limits or corrected to normal
- Female participants of reproductive age must have a negative serum pregnancy test within 7 days prior to medication and agree to use effective contraception during the study and for 3 months after
- Male participants with female partners of reproductive age must agree to use effective contraception during the study and for 3 months after
- Signed informed consent and willingness and ability to comply with study procedures
You will not qualify if you...
- Received radiotherapy, surgery, chemotherapy, immunotherapy for tumors, other investigational drugs, or live attenuated vaccines within 4 weeks before first study dose
- Planned surgery or radiation therapy for bone and soft tissue sarcomas during the study
- Use of immunosuppressive drugs within 14 days prior to first study dose, except nasal spray, inhaled corticosteroids, or physiological doses of systemic steroids
- Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks prior to first study dose or unexplained fever over 38.5°C during screening
- Poorly controlled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Significant bleeding or clotting events within 3 to 6 months prior to first study dose
- Active heart disease within 6 months prior to first study dose, including myocardial infarction, severe or unstable angina, low heart function, or poorly controlled arrhythmias
- Diagnosed with any other malignancy within 3 years prior to first study dose except certain skin or cervical cancers
- Known allergy to the study drug or its ingredients
- HIV infection, active hepatitis B or C infections
- Other serious medical conditions or disorders that may threaten safety, affect study results, or interfere with study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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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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