advanced lung squamous cell carcinom
Conditions
Interventions
Test group:3-day continuous intravenous pump of endostatin (endostar) combined with chemotherapy and immune checkpoint inhibito
Sponsors
First people’s Hospital of Yancheng,
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Aged from 18 to 75 years old (including 75 years old); 3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy; 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); 5. The Eastern Oncology Collaborative Group (ECOG) physical fitness status score is 0-1; 6. Expected survival time>3 months; 7. It has sufficient organ and bone marrow functions, and the laboratory test values within 7 days before enrollment meet the following requirements (no blood components, cell growth factors, albumin, or other corrective treatment drugs are allowed to be administered within 14 days before obtaining the laboratory test). The details are as follows ? Blood routine: Absolute neutrophil count (ANC) = 1.5 × 109/L, platelet (PLT) = 75 × 109/L, hemoglobin (HGB) = 90 g/L (no blood transfusion or erythropoietin dependency within 14 days), Liver function: serum total bilirubin (TBIL) = 2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 5 times ULN, and serum albumin = 28 g/L; Alkaline phosphatase (ALP) = 5 × ULN Renal function: serum creatinine (Cr) = 1.5 × ULN, or creatinine clearance rate = 50 mL/min (using the standard Cockcroft Gault formula): urine routine results show that urinary protein<2+; For patients with baseline urine routine testing showing urinary protein = 2+, 24-hour urine collection should be performed and 24-hour urinary protein quantification<1g.Coagulation function: International standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; If the subject is receiving anticoagulant treatment, as long as the INR is within the intended range of use of the anticoagulant drug. 8. For female subjects of reproductive age, a urine or serum pregnancy test should be conducted 3 days before receiving the first study drug administration and the results should be negative; 9. The subject and the subject's sexual partner need to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 2. Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose; 3. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; 4. Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias; 5. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; 6. Known allergic reactions to the study drugs; 7. Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible. 8. Symptomatic central nervous system metastases Patients with asymptomatic brain metastases or symptomatic stabilization of treated brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stable state for at least 2 weeks; Hormone therapy was stopped 3 days before the first dose of study drug; 9. Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose; 10. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or baseline, excluding fatigue or alopecia); 11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center); 13. Inoculate the live vaccine within 30 days before the first administration (cycle 1, day 1); 14. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free surviva;Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactDaixichao
Department of Oncology, Yancheng No.1 People's Hospital
Outcome results
None listed