soft tissue sarcoma (STS)
Conditions
Interventions
Experimental group:Tislelizumab + iribrin + arotinib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=16 years; 2. ECOG PS score 0-1; 3. Expected survival >=3 months; 4. Patients with pathologically confirmed distant metastases or locally advanced unresectable soft tissue sarcomas who have failed at least first-line standard treatment according to the investigator; 5. Patients should enter the study at least after the failure of standard first-line treatment (CSCO guidelines, NCCN guidelines,ESMO guidelines) and be assessed by the investigator as suitable for the current study regimen; 6. At least 1 measurable lesion >=1cm; 7. Normal function of major organs; 8. Use reliable contraceptive methods during the study; 9. Sign informed consent with my consent.
Exclusion criteria
Exclusion criteria: 1. Received antitumor therapy within 3 weeks before enrollment; 2. The previous systematic treatment regimen included both immune drugs and anti-vascular drugs, including PD-1/PD-L1/ ctLA4 antibodies, and anti-angiogenic drugs (such as antirotinib, solfantinib, Lunvatinib, Sunitinib, sorafenib, rigofenib, bevacizumab, Apatinib, etc.); 3. Surgery or radiation therapy is planned during the study period; 4. According to imaging findings, metastatic lesions of the central nervous system were present and not well controlled; Well controlled central system metastasis is excluded; 5. Used immunosuppressive drugs, such as dexamethasone more than 10mg/ day, within 14 days before enrollment; 6. Any history of active immune or autoimmune diseases, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Active or uncontrolled severe infection within 4 weeks prior to enrollment; 8. History of hypertension, which cannot be well controlled after drug treatment; 9. Bleeding symptoms of significant clinical significance or definite bleeding tendency occurred within 3 months before enrollment, or thromboembolism occurred within 12 months; 10. Persistent toxicity due to any prior antitumor therapy did not return to CTCAE 5.0 level 2; 11. Had grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc >=480ms), and >= grade 2 congestive heart failure (New York Heart Association (NYHA) grade) within 6 months prior to enrollment; 12. Diagnosed with other malignant tumors within 3 years prior to enrollment; 13. HIV positive, cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis requiring antiviral therapy; 14. Participated in clinical trials of other antitumor drugs within 3 weeks before enrollment; 15. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 16. The patient has any current disease or condition that affects drug absorption, or the patient is unable to take anrotinib orally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall Survival, OS;Adverse Event, AE;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactZhou Yuhong
Zhongshan Hospital, Fudan University
Outcome results
None listed