lung caner
Conditions
Interventions
three-day continuous Osmotic Pump of endostar combined with platinum-based chemotherapy plus Sindilizumab group:three-day continuous Osmotic Pump of endostar combined with platinum-based chemotherapy
Sponsors
Zigong First People's Hospital, Sichuan Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily agreed to participate and gave written informed consent. 2)Subjects with primary treatment of stage IIIB-IV NSCLC. 3)Subjects are negative for EGFR or ALK driver mutations. 4)No prior systemic antitumor therapy for advanced/metastatic disease. Patients who have received prior platinum-containing adjuvant/neoadjuvant chemotherapy or radical radiotherapy for progressive disease are allowed to be enrolled in this study if at least 6 months have elapsed between disease progression or recurrence and the end of the last chemotherapeutic drug treatment. 5)At least one imaging measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECIST version 1.1). 6)Eastern Collaborative Oncology Group (ECOG) physical status score of 0-1. 7)Expected survival time > 3 months. 8)Adequate organ and bone marrow function with laboratory test values within 7 days prior to enrollment meeting the following requirements (no blood components, cell growth factors, albumin and other corrective therapy medications are allowed to be given within the first 14 days of obtaining laboratory tests) as follows. 9) Blood routine: absolute neutrophil count (ANC) = 1.5 × 109/L, platelets (PLT) = 75 × 109/L, hemoglobin (HGB) = 90 g/L (no transfusion or erythropoietin-dependent within 14 days) 10) 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, serum albumin = 35 g/L; alkaline phosphatase (ALP) = 5 × ULN. 11) Renal function: serum creatinine (Cr) =1.5×ULN, or creatinine clearance =50 mL/min (applying the standard Cockcroft -Gault formula): urine routine results showing urine protein <2+; for patients whose urine routine test shows urine protein =2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification <1g should be performed. 12) Coagulation: international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; if the subject is on anticoagulation therapy, as long as the INR is within the proposed range of anticoagulant medication. 13) Age = 18 years and = 75 years. 14) For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed 3 days prior to receiving the first dose of study drug. 15) The subject and the subject's sexual partner are required to use a medically approved form of contraception (such as IUDs, birth control pills or condoms) during and for 6 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1) Patients with known EGFR-sensitive mutations or positive ALK rearrangements. 2) Those whose imaging (CT or MRI) shows tumor invasion of large blood vessels or those who, after evaluation, are expected to have a high likelihood of fatal hemorrhage due to tumor invasion of important blood vessels during the follow-up study. 3) Currently participating in an interventional clinical study treatment or have received another investigational drug or investigational device within 4 weeks prior to the first dose 4) Prior therapy with: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137). 5) Have received a proprietary Chinese medicine with an antitumor indication or an immunomodulatory agent (thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose, or have received major surgical treatment within 3 weeks prior to the first dose. 6) Presence of active hemoptysis, active diverticulitis, abdominal abscesses, gastrointestinal obstruction and peritoneal metastases requiring clinical intervention. 7) Class III-IV congestive heart failure (New York Heart Association Classification) with poorly controlled and clinically significant arrhythmias. 8) Any arterial thrombosis, embolism or ischemia such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment in therapy. 9) Known allergic reaction to PD-1/L1 monoclonal antibody, recombinant human vascular endothelial inhibitor active ingredient and or any excipients. 10) Patients requiring long-term systemic use of corticosteroids. Patients requiring intermittent use of bronchodilators, inhaled corticosteroids, or local injections of corticosteroids due to COPD, asthma may be enrolled. 11) Symptomatic central nervous metastases. Patients with asymptomatic brain metastases or treated brain metastases that are symptomatically stable may be enrolled in this study as long as all of the following criteria are met: measurable lesions outside the CNS; no midbrain, pontine, cerebellar, meningeal, medulla oblongata, or spinal cord metastases; maintenance of clinical steady state for at least 2 weeks; and discontinuation of hormone therapy 3 days prior to the first dose of study drug. 12) Have an active infection requiring treatment or have used systemic anti-infective drugs within one week prior to the first dose; 13) Have not recovered sufficiently from toxicity and/or complications from any intervention (i.e., = grade 1 or at baseline, excluding malaise or alopecia) prior to initiation of treatment 14) Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody). 15) Active untreated hepatitis B (defined as HBsAg positivity along with a detectable HBV-DNA copy number greater than the upper limit of normal values in the testing department of the study center). 16) Note: Subjects with hepatitis B who meet the following criteria may also be enrolled. 17) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of the study chemotherapy drug treatment 18) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is required 19) Active HCV-infected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor size; | — |
Secondary
| Measure | Time frame |
|---|---|
| T cell subsets; | — |
Countries
China
Contacts
Public ContactZhiping Deng
Outcome results
None listed