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

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ClinicalTrials.gov Identifier: NCT04356872
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
Tongji Hospital
Xijing Hospital
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Zhiguo Luo, MD, PhD, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Sintilimab Drug: Doxorubicin Hydrochloride Drug: Ifosfamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Multi Centers, Phase II Study of Sintilimab, Doxorubicin and Ifosfamide at First-line Treatment of Soft Tissue Sarcoma Including Undifferentiated Pleomorphic Sarcoma, Synovial Sarcoma, Myxoid Liposarcoma and De-differentiated Liposarcoma
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2023


Arm Intervention/treatment
Experimental: treatment
The patients with metastatic and unresectable soft tissue sarcoma including undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma will be enrolled and given sintilimab (PD-1) , doxorubicin and doxorubicin every three weeks for 6 cycles followed by sintilimab mono therapy till disease progression. The first enrolled six patients is safety run-in step for observing drug-limiting toxicity (DLTs). If the combinatory treatment is intolerable, the doses of chemo regimens will be reduced according to drug instruction.
Drug: Sintilimab
immune check point inhibitor, 200mg, iv, d1

Drug: Doxorubicin Hydrochloride
ADM, 60mg/m2, iv, d1
Other Name: ADM

Drug: Ifosfamide
IFO, 1.8 g/m2/d, d1-5
Other Name: IFO




Primary Outcome Measures :
  1. overall response rate, ORR [ Time Frame: up to two years ]
    the best response rate


Secondary Outcome Measures :
  1. progression free survival, PFS [ Time Frame: up to three years ]
    from first dose treatment to disease progression

  2. adverse events, AE [ Time Frame: up to three years ]
    treatment related adverse events, TRAEs

  3. overall survival, OS [ Time Frame: up to three years ]
    overall survival


Other Outcome Measures:
  1. PD-L1 expression [ Time Frame: up to two years ]
    PD-L1 expression will be detected by Immunohistologic chemistry, IHC or PCR method

  2. tumor infiltrating lymphocytes measurement [ Time Frame: up to two years ]
    tumor infiltrating lymphocytes will be measured by flowcytometry using tissue and/or peripheral blood sample;



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 treatment(not received anthracycline)replase 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 (HIV)or any acquired immunodeficiency syndrome, organ implantation;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356872


Contacts
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Contact: Xin Liu, MD 0086-021-64175590 jeanettexin@hotmail.com

Locations
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China, Shanghai
Fudan University, Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Xin Liu, MD    0086-18017317720    jeanettexin@hotmail.com   
Sponsors and Collaborators
Fudan University
Zhejiang Cancer Hospital
Tongji Hospital
Xijing Hospital
Shanghai Zhongshan Hospital
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Responsible Party: Zhiguo Luo, MD, PhD, Chief Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04356872    
Other Study ID Numbers: SAIS
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decide, need to discuss with all collaborators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhiguo Luo, MD, PhD, Fudan University:
PD-1
doxorubicin
ifosfamide
first line treatment
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents