Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-70
SponsorHenan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 10-70, both male and female.
The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. Subjects with amputation can be relaxed up to 2 points.
The expected survival time was ≥3 months.
Subjects with bone and soft tissue sarcomas with distant metastases or locally advanced disease who were not considered suitable for surgical treatment by the investigator.
Disqualifiers
Urine routine: urinary protein <2+; If urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; FT3(T3) and FT4(T4) levels should be examined if they are abnormal, and normal FT3(T3) and FT4(T4) levels can be selected.
Female subjects of reproductive age must have a negative serum pregnancy test within 7 days prior to medication and be willing to use a medically approved highly effective contraceptive (e.g., intrauterine device, birth control pill, or condom) during the study period and within 3 months after the last administration of the study drug; Male subjects with a female partner of reproductive age were required to undergo surgical sterilization or consent to use an effective method of contraception during the study period and for 3 months after the last study dose.
I have AGREED and signed the informed CONSENT, and I am willing AND ABLE TO comply with the planned visit, study treatment, laboratory tests and other trial procedures.
Trial design
Design model
Single group
Treatments tested in this trial
Lenvatinib mesylate capsule
DrugLenvatinib mesylate capsule, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg), orally, once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Lenvatinib mesylate capsuleOther 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival
From the start of treatment to the onset of disease progression or death of the patient
Time frame
Up to approximately 24months2
Objective response rate
Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it
Time frame
Up to approximately 24monthsSponsors and contacts
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Source ClinicalTrials.gov