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

NCT ID: NCT04356872

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2023-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

immune check point inhibitor, 200mg, iv, d1

Doxorubicin Hydrochloride

Intervention Type: DRUG

ADM, 60mg/m2, iv, d1

Ifosfamide

Intervention Type: DRUG

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

Interventions

Sintilimab

immune check point inhibitor, 200mg, iv, d1

Intervention Type: DRUG

Doxorubicin Hydrochloride

ADM, 60mg/m2, iv, d1

Intervention Type: DRUG

Ifosfamide

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

Intervention Type: DRUG

Other Intervention Names

ADM; IFO

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Luo, MD, PhD

Chief Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University, Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Liu, MD

Role: CONTACT

jeanettexin@hotmail.com

0086-021-64175590

Facility Contacts

Xin Liu, MD

Role: primary

jeanettexin@hotmail.com

0086-18017317720

Other Identifiers

SAIS

Identifier Type: -

Identifier Source: org_study_id