Temozolomide for Injection Combined With Epirubicin in First-line Treatment of Leiomyosarcoma

NCT05204524 | Unknown DMC

• 1 other identifier: 21/313-2984
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The objective curative effect of tumor was evaluated by recist version 1.1 standard, including the percentage of patients with complete remission and partial remission maintained for more than 4 weeks.

  42 days

Secondary Outcomes (2)

• Disease control rate

  42 days

• progression-free survival

  42 days

Study Arms (1)

Subjected arm

EXPERIMENTAL

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.

Drug: Temozolomide for injection combined with epirubicin

Interventions

Temozolomide for injection combined with epirubicin DRUG

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.

Subjected arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Or accompanied by other malignant tumors in the past, except the cured basal cell carcinoma of skin and carcinoma in situ of cervix; 2. Those who have been proved to be allergic to temozolomide, dacarbazine or DTIC, epirubicin and/or their auxiliary materials; 3. Special attention: Patients with gastrointestinal bleeding risk should not be included in the group, including the following situations: (1) Active peptic ulcer lesions with occult blood in stool (++); (2) Those who have a history of black stool and hematemesis within 3 months; (3) Gastroscopy must be performed for fecal occult blood (+) to determine whether organic diseases of gastrointestinal tract exist; 4. There were active heart diseases, including myocardial infarction, severe/unstable angina pectoris, etc. Echocardiographic left ventricular ejection fraction \< 50% and poorly controlled arrhythmia (including QTcF interval \> 450 ms for men and \> 470ms)； for women); 5. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 6 months before enrollment, or fever of unknown cause occurred during screening/before first administration \> 38.5°C；; 6. Those with abnormal coagulation function (INR\>1.5×ULN, APTT\>1.5×ULN) and bleeding tendency; 7. Pregnant or lactating women; Prohibited in patients with severe myelosuppression; 8. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or implement the research requirements; 10. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 11. According to the judgment of the researcher, there are accompanying diseases that seriously endanger the patient's safety or affect the patient's completion of the study;
• Rejection study:
• Failure to use drugs according to the provisions of this plan leads to failure to evaluate the effectiveness and/or safety;
• In the course of research and treatment, researchers are allowed to give corresponding supportive treatment according to the clinical needs of subjects, and anti-tumor treatment not specified in the research scheme is prohibited in the course of treatment, but medical measures taken for tumor emergencies that endanger patients' lives are not included.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Leiomyosarcoma

Interventions

Temozolomide; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of internal medicine

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: August 27, 2021
• Primary Completion: August 27, 2022
• Study Completion: August 27, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

CN (1)