Soft tissue sarcoma
Conditions
Interventions
Group A :Adebrelimab (1200 mg,i.v.,d1, q3w)
Group B :Famitinib (20 mg,p.o.,qd, continuously)
Group C:Adebrelimab(1200 mg,i.v.,d1, q3w),
Famitinib(20 mg,p.o.,qd,continuously).
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18-75 years old, gender not limited; 2) ECOG score: 0-1 points; 3) Expected survival period >= 3 months: 4) Late stage or metastatic soft tissue sarcoma diagnosed by histology or cytology; 5) The patient has received second-line chemotherapy or targeted or immunotherapy in the past; 6) At least one measurable lesion as the target lesion (according to RECIST v1.1 criteria); 7) Allow patients to have previously received TKIs or immune checkpoint inhibitors other than adebrelimab or famitinib. 8) Major organs function well, that is, they meet the following criteria: ?neutrophils > =1.5x 109/L; ?white blood cells > = 3.0 x 109/L; ? Platelet > = 100x109/L; ?hemoglobin > = 90 g/L; ?Serum albumin > =30 g/L; ?Total bilirubin =60 mL/ min or serum creatinine <=1.5 x ULN; ?INR < =1.5 x ULN and APTT<=1.5 x ULN (screening is possible for stable dose anticoagulants such as low molecular weight heparin or warfarin and INR is within the intended therapeutic range of anticoagulants); ?Electrocardiogram: QTc<=450 ms (male), < =470 ms (female);; 9) Women of childbearing age must undergo a blood pregnancy test within 14 days before enrollment, and the result must be negative. They must also be willing to use appropriate contraception methods during the trial period and for 6 months after the end of treatment. For males, surgical sterilization should be performed, or they should agree to use appropriate contraception methods during the study period and within 3 months after the end of treatment; 10) Voluntarily participate in this study and sign an informed consent form; 11) Good compliance, agree to cooperate and receive survival follow-up.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions are not eligible for inclusion in this study: 1) Patients who have previously been treated with adebrelimab or famitinib; 2) Patients who are known to be allergic to the ingredients of the drug in this study; 3) Suffering from malignant tumor diseases other than those treated in this study, excluding: cured and non recurrent malignant tumors within 3 years prior to study enrollment, completely resected basal cell and squamous cell skin cancer, and completely resected in situ cancer of any type 4) Active central nervous system metastases (whether treated or not), including symptomatic brain metastases, meningeal metastases, or spinal cord compression; Exclusion: Asymptomatic brain metastases (no progression within 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 flow; 6) The toxicity of previous treatments is still above level 1 (CTCAE V5.0 standard), excluding hair loss and neurotoxicity; 7) Individuals with a history of mental disorders; 8) Individuals with a history of drug use or substance abuse have been questioned; 9) Patients with a history of idiopathic pulmonary fibrosis or idiopathic pneumonia, or those who have undergone extensive radiation therapy for the lungs; 10) Complications that require treatment with immunosuppressive drugs, or complications that require systemic or local use of corticosteroids at doses with immunosuppressive effects (prednisone>10 mg/day or equivalent doses of similar drugs); 11) Have a history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except for: type I diabetes, hypothyroidism that can be controlled only through hormone replacement therapy, skin diseases that do not need systemic treatment (such as vitiligo, psoriasis), controlled celiac disease, or diseases that are not expected to recur if there is no external stimulus; 12) Individuals who have previously or currently have active tuberculosis infection; 13) Active infections that require systemic treatment; 14) Uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >= 90 mmHg) or pulmonary hypertension or unstable angina pectoris; Have had a myocardial infarction or undergone bypass or stent surgery within 6 months prior to administration; History of chronic heart failure meeting NYHA criteria 3-4; Valve disease with clinical significance; Severe arrhythmias requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interval >= 450 ms in males and >= 470 ms in females; Cerebrovascular accident (CVA) or transient ischemic attack (TI, etc.) within 6 months prior to administration; 15) Complicated with serious medical diseases, including but not limited to: uncontrolled diabetes, active gastrointestinal ulcer, active bleeding, etc; 16) Positive for Anti HIV, TP Ab, and HCV Ab; HBV Ag positive and HBV DNA copy number>1000; 17) Expected major surgery within 28 days prior to administration or during treatment;. 18) Expected to receive live or attenuated vaccines 4 weeks before administration, during treatment, or within 5 months of the last administration; 19) Within 30 days prior to administrat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month Progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Clinical benefit rate;Time to progression;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactDan Song
Jiangsu Cancer Hospital
Outcome results
None listed