SHR-1701 Combined With Fluzoparib as Maintenance Therapy for Advanced Lung Squamous Cell Carcinoma After Platium Based Chemo-immunotherapy
The purpose of the trial was to evaluate the efficacy and safety of SHR-1701 combined with fluzopar as a first-line treatment maintenance therapy for advanced lung squamous cell carcinoma. Patients with advanced or metastatic (stage IV) lung squamous cell carcinoma have not received systemic chemotherapy and have measurable lesions (RECIST 1.1) ECOG PS 0-1. The patient received SHR1701 +fluzoparib
• 1.The age at the time of signing the informed consent form is 18-75 years old, both male and female;
• 2.Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology;
• 3.Has not received systemic treatment for the recurrence or metastasis stage in the past. If you have received neoadjuvant or adjuvant chemotherapy/radiotherapy in the past, those who have relapsed or metastasized\> 6 months from the end of treatment can be included in the group.
• 4.ECOG PS score: 0-1 points;
• 5.According to the RECIST 1.1 standard, the patient must have at least one measurable lesion;
• 6.The function of major organs is normal, that is, it meets the following standards: a) Routine blood examination (under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ) ≥1.5×109/L; platelet (PLT) ≥100×109/L; white blood cell count (WBC) ≥3.0×109/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ×Upper limit of normal (ULN); serum total bilirubin (TBIL)≤1.5×ULN; serum creatinine (Cr)≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
• 7.Expected survival period ≥ 3 months; Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, surgical sterilization should be performed Or agree to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
• 8.The patient voluntarily participates and signs the informed consent form (or signed by the legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.