A Prospective, Randomized Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Endostar Combined With AI Regimen Compared With AI Regimen in Adjuvant Treatment After Radical Resection of Recurrent Soft Tissue Sarcoma
Overview
- Phase
- Phase 2
- Intervention
- Endostar (recombinant human endostatin injection)
- Conditions
- Other Disorders of Soft Tissues
- Sponsor
- Yong Chen
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- EFS （Event-Free Survival Rate）
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Yong Chen
Chief Physician
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Patients with soft tissue sarcoma confirmed by histopathology and cytology;
- •Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma;
- •Patients who have previously undergone surgery can be included in the group, but according to the researcher's evaluation, they must have recovered and the operation completion time is at least 4 weeks from the study entry;
- •Local radiotherapy can be received during chemotherapy;
- •Have received anti-tumor drug treatment in the past, including adjuvant or neoadjuvant chemotherapy, but it has been over 6 months before the start of the study treatment;
- •R0 resection after local recurrence, non-chemotherapeutic resistant soft tissue sarcoma, including synovial sarcoma, pleomorphic liposarcoma, myxoid/round cell liposarcoma, pleomorphic undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, Angiosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, etc., except Ewing's sarcoma, embryonic/acinoid rhabdomyosarcoma and other sarcomas that do not use AI regimen as the first-line chemotherapy regimen, and some chemotherapy-insensitive sarcomas: highly differentiated/removed Differentiated liposarcoma, clear cell sarcoma, alveolar soft tissue sarcoma, extraosseous mucinous chondrosarcoma, etc.;
- •No gender limit, ≥18 years old;
- •ECOG score ≤ 2;
- •The expected survival period is ≥3 months;
- •Sufficient blood function: absolute neutrophil count (ANC)≥1.5×109/L and platelet count≥80×109/L and hemoglobin≥9 g/dL;
Exclusion Criteria
- •Pregnant or lactating women, or female patients who are fertile but have not taken contraceptive measures;
- •There are severe acute infections that have not been controlled; or there are purulent and chronic infections, and the wounds do not heal;
- •There is a second primary tumor (except skin basal cell carcinoma);
- •Those who have participated in other drug clinical trials within 4 weeks.
- •Pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
- •People with uncontrollable neurological or mental illnesses or mental disorders, poor compliance, and unable to cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatry Symptoms;
- •Those with bleeding tendency;
- •Evidence of hereditary hemorrhagic constitution or coagulopathy;
- •A clear history of allergy to chemotherapy drugs
Arms & Interventions
Endostar combined with 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 uses 15 medicines per cycle, 15 Endostar medicines 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.
Intervention: Endostar (recombinant human endostatin injection)
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.
Intervention: Chemotherapy AI
Observation group
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. In the course of medication, if the disease progresses or the researcher believes that the patient is not suitable for continuing medication, the medication will end.
Intervention: Endostar (recombinant human endostatin injection)
Outcomes
Primary Outcomes
EFS （Event-Free Survival Rate）
Time Frame: 2 year
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.
Secondary Outcomes
- OS（Overall Survival）(2 year)