A Phase II Study of Temozolomide for Injection Combined With Epirubicin in the First-line Treatment of Leiomyosarcoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a single-center, prospective, one-arm clinical study, which is planned to be carried out in Cancer Hospital of Chinese Academy of Medical Sciences. The patients with locally advanced or metastatic leiomyosarcoma who are inoperable are enrolled, aiming at the effectiveness and safety of temozolomide for injection combined with epirubicin as the first-line treatment for advanced leiomyosarcoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
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• Patients voluntarily participated in this study and signed informed consent; 2. Unresectable, locally advanced or metastatic leiomyosarcoma, and never received systemic treatment, including chemotherapy, targeted therapy and immunotherapy; 3.18

‣ 70 years old (including 18 and 70 years old), male or female. 4.ECOG PS score: 0

‣ 2 points; 5. The estimated survival time is more than 3 months; 6. The main organ function meets the following criteria within 7 days before treatment:

‣ A. blood routine examination standard (without blood transfusion within 14 days):

‣ hemoglobin (HB) ≥ 90g/l; ② absolute neutrophil count (ANC) ≥ 1.5× 109/l; ③ platelet (PLT)≥80×109/L ..

‣ B. biochemical examination shall meet the following standards:

‣ total bilirubin (TBIL)≤1.5 times the upper limit of normal value (uln);

‣ Alanine aminotransferase (ALT) and aspartate aminotransferase AST≤2.5ULN, and ALT and AST ≤ 5 ULN with liver metastasis;

‣ serum creatinine (Cr)≤1.5ULN or creatinine clearance rate (CCR) ≥ 55ml/min; C. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)≥ the lower limit of normal value (50%).

⁃ Women of childbearing age should agree that contraceptive measures (such as intrauterine device, contraceptive pill or condom) must be used during the study and within 6 months after the end of the study; Serum or urine pregnancy test was negative within 7 days before the study entered the group, and it must be a non-nursing patient. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

⁃ There must be at least one measurable lesion meeting the RECIST 1.1 standard (the measured diameter line shall be based on the longest diameter of the lesion ≥10mm, and the shortest diameter of lymph nodes ≥15mm).

Locations
Other Locations
China
Cancer Hospital of Chinese Academy of Medical Sciences
Recruiting
Beijing
Time Frame
Start Date: August 27, 2021
Estimated Completion Date: August 27, 2023
Participants
Target number of participants: 28
Treatments
Experimental: Subjected arm
temozolomide for injection (once a day, with a fixed dose of 200 mg (body surface area ≤1.7m2) or 300 mg (body surface area > 1.7 m2), for 5 days, with 21 days as a cycle) combined with epirubicin (60 mg/m2 21-day scheme).~Temozolomide for injection, according to the requirements of GCP, the test drug should be sealed, kept away from light and kept at 2-8℃, with a valid period of 24 months.
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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