The Combination of Sintilimab and AI (Doxorubicin ADM/Ifosfamide IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    45
  • sponsor
    Fudan University
Updated on 25 January 2021
measurable disease
doxorubicin
metastasis
neutrophil count
cancer chemotherapy
solid tumour
ifosfamide
soft tissue sarcoma
liposarcoma
synovial sarcoma
undifferentiated pleomorphic sarcoma
myxoid liposarcoma

Summary

This is a phase II trial to explore the feasibility of PD-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.

Details
Condition Sarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma
Treatment doxorubicin hydrochloride, ifosfamide, Sintilimab
Clinical Study IdentifierNCT04356872
SponsorFudan University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women aged 18-75 years
Provide written informed consent
Local advanced or metastatic unresectable sarcoma
Histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Life span expectation over 3 months
Absolute neutrophil count (ANC) 1,500/mcL (within 7 days of treatment initiation)
Hemoglobin 9 g/dL (within 7 days of treatment initiation)
Platelets 90,000/mcL (within 7 days of treatment initiation)
Serum creatinine 1.5 X upper limit of normal (ULN) or creatinine clearance [CrCl]) 50 mL/min for subject with creatinine levels (within 7 days of treatment initiation)
Serum total bilirubin 1.5 X ULN (within 7 days of treatment initiation)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) 2.5 X ULN or =< 5 X ULN for subjects with liver metastases (within 7 days of treatment initiation)

Exclusion Criteria

Prior systemic therapy for advanced and metastatic disease, except adjuvant treatmentnot received anthracyclinereplase over 6 months
Received any testing anti-cancer drugs within four weeks of treatment initiation
Prior immune related therapy including but not limited to PD-1, PD-L1, CD137, CTLA4, T cell stimulation, check point inhibitor etc
Symptomatic, untreated, or uncontrolled brain metastases present
clinical meaningful active bleeding
Other malignant cancer history rather than soft tissue sarcoma within five year prior to treatment initiation
Have active infections requiring therapy
Have active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study
Pregnant or breast-feeding
Any serious or unstable medical condition or mental illness
Serious systemic diseases such as heart disease, history of (non-infectious) pneumonitis
Active HBV >10000 copy/ml and HCV RNA> 1000copy/ml infection
Positive human immunodeficiency virus (HIVor any acquired immunodeficiency syndrome, organ implantation
Clear my responses

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