Advanced L-type sarcoma
Conditions
Interventions
Control group:Doxorubicin alone
Intervention group:Eribulin plus anlotinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients with pathologically confirmed unresectable locally advanced or metastatic leiomyosarcoma or liposarcoma; (2) Aged >=18 and =1,500/µL, platelet count >=80,000/µL, and hemoglobin >=9.0 g/dL; (7) International normalized ratio (INR) =50%; (11) Non-surgically sterilized female patients of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) test within 7 days prior to enrollment and must be willing to use adequate contraception during the study period and for 3 months after the last dose of the study drug. Male patients must agree to use adequate contraception during the study period and for 3 months after the last dose or have undergone surgical sterilization; (12) No prior systemic chemotherapy or targeted therapy for advanced leiomyosarcoma or liposarcoma; no prior treatment with anthracycline or anthracenedione agents; patients who received neoadjuvant or adjuvant therapy must not have received chemotherapy, and disease progression must have occurred >6 months after completion of neoadjuvant or adjuvant treatment; (13) All prior treatment-related toxicities from adjuvant anticancer therapy must have recovered to <= grade 1 (CTCAE v5.0), except for alopecia which may be at any grade; (14) Patients voluntarily agree to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Concurrent diagnosis of another malignancy, or history of a different type of malignancy with a disease-free interval of less than 3 years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix); (2) Symptomatic brain metastases; (3) History of Grade 3 or higher neurotoxicity related to prior anti-microtubule therapy; (4) Prior use of anlotinib hydrochloride capsules or other anti-angiogenic agents (including, but not limited to, pazopanib, apatinib, lenvatinib, sunitinib, etc.); (5) Active infections, such as HIV infection, hepatitis B virus DNA >=1×10^3 copies/mL, positive hepatitis C antibody, active tuberculosis, etc.; (6) Women who are lactating or pregnant; (7) Radiotherapy within 28 days before treatment; (8) Major surgery or significant trauma within 28 days before treatment; (9) Severe cardiovascular or cerebrovascular disease, including: 1) Poorly controlled hypertension (systolic blood pressure >=150 mmHg or diastolic blood pressure >=90 mmHg); 2)Unstable angina, myocardial infarction, or coronary stenting within 12 months before the first dose; 3) Poorly controlled arrhythmias (including QTc interval >=450 ms in males or >=470 ms in females); 4) Cardiac insufficiency of NYHA Class II or higher, or left ventricular ejection fraction (LVEF) =3 within 28 days before treatment; or presence of unhealed wounds, fractures, active gastric or duodenal ulcers, ulcerative colitis, other gastrointestinal disorders, or active bleeding from unresected tumors; or any condition deemed by the investigator to potentially cause gastrointestinal bleeding or perforation; (15) Factors that may interfere with oral administration or drug absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.); (16) Any other condition considered by the investigator to render the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival period;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactYaotiao Deng
West China Hospital, Sichuan University
Outcome results
None listed