TNBC
Conditions
Interventions
Test group:Surufatinib :250mg QD P.O, ,
Zimberelimab :360mg I.V D1 , ,
nab-paclitaxel:100mg/m2 I.V D1,D8.
Sponsors
Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Willing to join the study and sign the informed consent form; 2) Male or female patients aged = 18 years old; 3) Histological examination confirmed TNBC (according to the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of breast cancer 2022 for molecular typing criteria), that is, HER2 (human epidermal growth factor receptor 2), ER (estrogen receptor), PR (progesterone receptor) are negative; 4) Definite at least one measurable lesion that meets the requirements of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; if the lesion that has previously received local therapy (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, there must be a clear imaging basis for the disease progression of the lesion; 5) Patients with locally advanced (staging according to AJCC version 8) inoperable, or recurrent/metastatic TNBC who have received = 1 line of systemic therapy are judged by the investigator to be suitable for continuing paclitaxel drug therapy (no previous paclitaxel treatment, or meet any of the following requirements: ? taxane neoadjuvant therapy is effective; ? Recurrence 1 year after the end of adjuvant therapy with taxanes; ? withdrawal after effective rescue therapy with taxanes); 6) performance status score (ECOG) = 2; 7) toxicity of previous anti-tumor therapy recovered to = grade 1 (except alopecia, pigmentation or other toxicities that were considered by the investigator to have no safety risk to the patient); 8) laboratory tests: neutrophils = 1.5 × 109/L;Platelets = 75 × 109/L; hemoglobin = 90 g/L; serum creatinine = 1.5 times the upper limit of normal and creatinine clearance = 60 ml/min; urine routine examination showed urine protein < 2 +; if urine protein = 2 +, 24-hour urine protein quantification should be < 1 g; alanine aminotransferase and aspartate aminotransferase = 1.5 times the upper limit of normal, or = 3 times the upper limit of normal in the presence of liver metastasis; total bilirubin = 1.5 times the upper limit of normal; albumin = 3.0 g/dL; coagulation function: prothrombin time (PT), international normalized ratio (INR) = 1.5 x ULN; 9) female patients had negative urine or blood HCG (except menopause and hysterectomy), and female patients of childbearing age and their partners took effective contraceptive measures during the trial and within 6 months after the end of the last medication (e.g., combined hormone (containing estrogen and progesterone) combined with inhibition of ovulation, progesterone contraception combined with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy, avoidance of sexual behavior, etc.).
Exclusion criteria
Exclusion criteria: 1) Patients who are known to be allergic to recombinant anti-PD-1 fully human monoclonal antibody drugs and their components, or known to be allergic to Surufatinib ,or nab- paclitaxel components; 2) Patients who have had a second tumor within the past 5 years, except cured cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma or carcinoma in situ at any other site; 3) Uncontrolled serious medical diseases that, in the opinion of the investigator, would affect the patient 's ability to receive treatment with the study regimen, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled infection, etc.; 4) Patients who currently have active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or patients who have previous gastrointestinal perforation or gastrointestinal fistula and have not recovered after surgical treatment; 5) Patients with evidence or history of bleeding tendency within 2 months before the first dose (such as melena, hematemesis, hemoptysis, bloody stool, etc.); 6) Patients with tumor invasion of the great vessel structure, such as pulmonary artery, superior vena cava or inferior vena cava, which is judged by the investigator to have a greater risk of bleeding; 7) Patients with a history of arterial thrombosis or deep venous thrombosis within 6 months before the first dose; or patients with stroke events and/or transient ischemic attack within 12 months; patients with implantable intravenous infusion pump or catheter-derived thrombosis, or superficial venous thrombosis,Patients with stable thrombus after conventional anticoagulant therapy are excluded; 8) receiving chemotherapy, targeted therapy, immunotherapy, clinical trials of other investigational drugs within 4 weeks before the first treatment; 9) pregnant or lactating female patients; 10) having any other diseases, metabolic disorders, physical examination results or abnormal laboratory test results, and there are reasons to suspect that it may lead to contraindications to the use of investigational drugs, or affect the reliability of study results; 11) major surgery within 28 days before the first treatment, or radiotherapy within 14 days before the first treatment, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before the first treatment; 12) other patients who are not suitable for participating in this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactCaixia Wang
Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed