Endostar Combined With AI Regimen Compared With AI in Adjuvant Treatment

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    210
  • sponsor
    Yong Chen
Updated on 28 January 2021

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.

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.

Details
Condition Other Disorders of Soft Tissues
Treatment Endostar (recombinant human endostatin injection), Chemotherapy AI
Clinical Study IdentifierNCT04699214
SponsorYong Chen
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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)1.5109/L and platelet count80109/L and hemoglobin9 g/dL
Sufficient liver function: total bilirubin upper limit of normal (ULN); AST and ALT 1.5 times upper limit of normal (ULN); alkaline phosphatase 5 times upper limit of normal (ULN)
Sufficient renal function: serum creatinine upper limit of normal (ULN) or calculated creatinine clearance 60 mL/min
The electrocardiogram is basically normal, and there is no unhealed wound on the body
Those who have not had a severe allergic reaction to biological agents, especially E. coli genetic engineering products
Women of childbearing age must agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy within 7 days before study entry The test is negative and must be a non-lactating patient; men should agree to use contraception during the study period and within 6 months after the end of the study period
The patient voluntarily joined the study, signed an informed consent form, had good compliance, and was able to be followed up by the trial staff

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
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