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
Qualifiers
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
Treatments tested in this trial
- Lenvatinib mesylate capsule
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov