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

NCT04356872 | Unknown Phase 2

• 1 other identifier: SAIS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma, Soft Tissue

Keywords

PD-1; doxorubicin; ifosfamide; first line treatment

Outcome Measures

Primary Outcomes (1)

• overall response rate, ORR

  the best response rate

  up to two years

Secondary Outcomes (3)

• progression free survival, PFS

  up to three years

• adverse events, AE

  up to three years

• overall survival, OS

  up to three years

Other Outcomes (2)

• PD-L1 expression

  up to two years

• tumor infiltrating lymphocytes measurement

  up to two years

Study Arms (1)

treatment

EXPERIMENTAL

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; Drug: Doxorubicin Hydrochloride; Drug: Ifosfamide

Interventions

Sintilimab DRUG

immune check point inhibitor, 200mg, iv, d1

treatment

Doxorubicin Hydrochloride DRUG

ADM, 60mg/m2, iv, d1

Also known as: ADM

treatment

Ifosfamide DRUG

IFO, 1.8 g/m2/d, d1-5

Also known as: IFO

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)；

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead
• Zhejiang Cancer Hospital: collaborator
• Tongji Hospital: collaborator
• Xijing Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Fudan University, Cancer Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

sintilimab; Doxorubicin; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xin Liu, MD

CONTACT

0086-021-64175590; jeanettexin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical Professor

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 22, 2020
• Study Start: April 8, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2023
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

CN (1)