soft tissue sarcoma
Conditions
Interventions
experimental group:envafolimab combined with AI
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 70 years; 2. Patient with histologically or cytologically confirmed high grade soft tissue sarcoma, and the pathological types that are moderately sensitive to anthracycline chemotherapy and above; 3. Patients have never accepted anthracycline, isophosphamide, any immuno-checkpoint inhibitors and TNF intra-tumors injection therapy; 4. Measurable disease according to the RECIST1.1; 5. ECOG/PS 0-2; Estimated survive>6 months; 6. Recovery from previous treatment. All side effects (except alopecia) subsided to level 1 or below according to NCI-CTCAE 5.0. 7. Normal function of major organs should meet the following criteria: 1) HB>=95 g/L; 2) ANC>=1.5x10^9/L; 3) PLT>=80x10^9/L; 4)Serum Cr= 35 g/L; 9)PT and APTT =50%; 11)Blood pressure was controlled within 140/90 mmHg before enrollment ; 8. Women of childbearing age are willing to use appropriate methods of contraception during the test and 8 weeks after having the last experimental drug. Women of childbearing age should have a pregnancy check before test (within 7 days). The result should be negtive. Men are willing to use appropriate methods of contraception during the test and 8 weeks after having the last experimental drug or have experienced surgically sterilized; 9. Informed consent (or legal agent) should be signed to demonstrate their knowledge of the purpose and the operation required and show their willingness to participate in the study.
Exclusion criteria
Exclusion criteria: 1.The patient has any active autoimmune disease or has a history of autoimmune disease; 2.Other malignant tumors that have occurred or are currently concurrently present within five years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) ) and T1 (tumor infiltrating basement membrane)]; 3.Active infection requiring systemic treatment; 4.Patients with uncontrolled cardiac diseases, such as (1) heart failure of NYHA II or above; (2) unstable angina; (3) myocardial infarction within 1 year; (4) patients with clinical meaningful supraventricular or ventricular arrhythmias (5) QTc>450ms (male)QTc>470ms (female) 5. Requires cortisol (>10 mg/day prednisone or equivalent) or other systemic immunosuppressive drugs (except inhaled or topical corticosteroids) within 14 days prior to study treatment or prednisone at doses greater than 10 mg/day or equivalent in replacement therapy; 6.Patients with past and current objective evidence of interstitial lung disease; 7.Less than 4 weeks before the study medication or possibly inoculated with live vaccine during the study period; 8.Pregnant or lactating patients; 9.Known history of human immunodeficiency virus (HIV); 10.Known active hepatitis B or C; 11.Patients with known mental illness or substance use disorder; 12.According to the judgment of the researcher, the patients have other factors that may cause the study to be terminated halfway. If there is a serious abnormal laboratory test, accompanied by family or social factors, it will affect the safety of the patients, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival, OS;Adverse Reactions, AR;Relationship between tumor remission and expression of immune biomarkers; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Outcome results
None listed