To evaluate the effectiveness, safety and tolerability of Endostar (recombinant human endostatin) combined with AI chemotherapy in adjuvant treatment after radical resection of recurrent soft tissue sarcoma.
Eligible patients with stage IIB/III soft tissue sarcoma after surgical treatment for local recurrence were randomly divided into three groups: Group A: Endostar combined chemotherapy AI Endostar: Endostar 45mg/d, D1-5 iv, Q3W, that is, continuous intravenous pump injection for 120 hours for 5 consecutive days, one cycle. Endostar takes 15 medicines per cycle, and a Baxter pump per single cycle. Subjects buy and use them at their own expense every two cycles. AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. Group B:Chemotherapy AI AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W. Group C: Observation group Best supportive treatment, observation and follow-up. The dose of Endostar is not adjusted, and the specific adjustment plan of the chemotherapy regimen is adjusted according to the clinical experience of the investigator. Patients with no disease progression (local tumor recurrence, distant metastasis, or the appearance of new lesions of the same tumor subtype) and the adverse reactions can be tolerated, continue to use the drug for 6 cycles, and cannot receive other anti-tumor treatments. During the medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
The experimental group is Endostar combined with AI
AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGEFS (Event-Free Survival Rate)
Prospective observation of the 2-year event-free survival rate EFS (Event-Free Survival Rate) of recombinant human endostatin injection (Endostar, trade name: Endostar) combined with adjuvant chemotherapy for local recurrence of soft tissue sarcoma, ie no progress , No disease-related deaths, no time for new lesions.
Time frame: 2 year
OS(Overall Survival)
To evaluate the OS (Overall Survival)
Time frame: 2 year
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