Lung cancer
Conditions
Interventions
Experimental group:Recombinant human endostatin + PD1 inhibitor + chemotherapy
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed the informed consent; 2. Aged 18-80 years, no gender limit; 3. Advanced (inoperable and unwilling to radiotherapy) or metastatic (IIIB, IIIC or IV) squamous NSCLC confirmed by histology or cytology, and no mutation in driver gene detection; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST1.1), at least one measurable lesion should be used as a target lesion, and the measurable lesion should not have received local treatment such as radiotherapy; 5. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0-2 points; 6. Expected survival period >= 3 months; 7. Naive patients who have not received systemic antitumor therapy, including radiotherapy and chemotherapy, targeted and immunotherapy, or patients who have relapsed after adjuvant chemotherapy after surgery for more than 6 months; 8. Major organ function within 7 days prior to treatment, meeting the following criteria: (1) Routine blood test standards (without blood transfusion within 14 days): hemoglobin (HB) >= 90g/L, absolute neutrophil value (ANC) >= 1.5x10^9/L, platelet (PLT) >= 80x 10^9/L; (2) Biochemical tests must meet the following criteria: total bilirubin (TBIL) =60ml/min, serum albumin>=35g/L; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%); 9. Tissue samples are required for biomarker (such as PD-L1) analysis, preferably newly obtained tissue, patients who cannot provide newly obtained tissue can provide 5-8 paraffin sections with a thickness of 3-5 µm that have been archived within 2 years before enrollment.
Exclusion criteria
Exclusion criteria: 1. Severe allergic/anaphylactic reactions to humanized antibodies or fusion proteins; 2. Known to have hypersensitivity reactions to Endostat or any component contained in the antibody preparation; 3. Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of the study, allowing the use of physiological doses of glucocorticoids (=2000IU/ml or 10^4copies/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the detection limit of the analytical method); 9. According to chest X-ray examination, sputum examination and clinical physical examination, it is judged to have active pulmonary tuberculosis (TB) infection. Patients with a history of active pulmonary tuberculosis infection within the previous 1 year, even if they have been treated, should be excluded; patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded unless the duration and type of anti-tuberculosis treatment previously used are proved to be appropriate; 10. Patients with brain metastases with symptoms or symptom control time less than 2 months; 11. Received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before grouping; 12. No matter the severity, patients with any signs of bleeding constitution or medical history; patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before assignment, with unhealed wounds, ulcers or fractures; 13. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 14. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 15. There are cases where other investigators judge that they are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactZhang Jianqing
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed