Soft tissue sarcoma
Conditions
Interventions
Treatment group:Chemotherapy Combined with Anti-Angiogenic Therapy and Immunotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years, no restriction on gender; 2.Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1; 3.Estimated overall survival >= 3 months; 4.Histologically or cytologically confirmed advanced or metastatic soft tissue sarcoma; 5.No prior systemic anti-tumor therapy received; 6. At least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); 7. Major organ function is good, meeting the following criteria: (1) Neutrophils >=1.5×10^9/L; (2) White blood cells >=3.0×10^9/L; (3) Platelets >=100×10^9/L; (4) Hemoglobin >=90 g/L; (5) Serum albumin >=30 g/L; (6) Total bilirubin =60 mL/min or serum creatinine <=1.5×ULN; (9) INR <=1.5×ULN and APTT <=1.5×ULN (for those on stable doses of anticoagulants such as low molecular weight heparin or warfarin, and INR is within the expected therapeutic range, eligibility may be considered); (10) ECG: QTc <=450 ms (male), <=470 ms (female); 8. Women of childbearing potential must have a negative blood pregnancy test within 14 days before enrollment and agree to use appropriate contraception during the study and for 6 months after treatment. Men must be surgically sterilized or agree to use appropriate contraception during the study and for 3 months after treatment; 9. Voluntarily participate in this study and sign the informed consent form; 10. Good compliance, agreeing to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients previously treated with adebrelimab or apatinib; 2.Patients with known hypersensitivity to any components of the study drugs; 3.Patients suffering from other malignant tumors besides the tumor investigated in this study. Exclusions: Malignant tumors that are cured and have not recurred within 3 years prior to study enrollment, completely resected basal cell and squamous cell skin cancers, and completely resected any type of in situ cancer; 4. Active central nervous system metastases (regardless of previous treatment), including symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression; Exclusion: asymptomatic brain metastases (with no progression for at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection, not requiring dexamethasone or mannitol treatment); 5. Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage; 6. Previous treatment-related toxicity greater than grade 1 (CTCAE V5.0 criteria), excluding alopecia and neurotoxicity; 7. History of psychiatric disorders; 8. History of drug use or abuse after inquiry; 9. History of idiopathic pulmonary fibrosis or idiopathic pneumonia, or patients who have undergone large-area pulmonary radiotherapy; 10. Comorbidities requiring immunosuppressive drug treatment, or comorbidities requiring systemic or local use of corticosteroids at immunosuppressive doses (prednisone >10 mg/day or equivalent drugs); 11. History of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.; Exclusion: type 1 diabetes, hypothyroidism controlled only by hormone replacement therapy, skin diseases not requiring systemic treatment (such as vitiligo or psoriasis), controlled celiac disease, or diseases not expected to recur in absence of external triggers; 12. Current or previous active tuberculosis infection; 13. Active infections requiring systemic treatment; 14. Uncontrolled hypertension (systolic >=140 mmHg and/or diastolic >=90 mmHg), pulmonary hypertension, or unstable angina; myocardial infarction or bypass/stent surgery within 6 months prior to administration; history of chronic heart failure NYHA class 3-4; clinically significant valvular disease; severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), including QTc interval =450 ms in men and =470 ms in women; cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to administration; 15. Severe concomitant medical conditions, including but not limited to uncontrolled diabetes, active gastrointestinal ulcers, active bleeding, etc.; 16. Positive anti-HIV, TP-Ab, or HCV-Ab; positive HBV-Ag with HBV DNA copies >1000; 17. Major surgery expected within 28 days prior to administration or during treatment; 18. Live or attenuated vaccines expected to be administered 4 weeks prior to administration, during treatment, or within 5 months after last administration; 19. Participation in another clinical trial and receipt of investigational drug treatment within 30 days prior to administration; 20. Inadequate patient communication, understanding, or cooperation, or poor compliance, unable to ensure adherence to the protocol; 21. Other reasons deemed by the investigator making the patient unsuitable to participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWang Chunmeng; Zheng Biqiang
Fudan University Shanghai Cancer Center
Outcome results
None listed