Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment for ES-SCLC：A Prospective, Single-center, Single-arm Clinical Study
At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying. Selinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy/radiotherapy/targeted therapy exhibits significant anti-tumor activity. This study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.
• Age ≥ 18 years old, male or female;
• ECOG PS score 0-1 points;
• Expected survival period is not less than 12 weeks;
• Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World Health Organization);
• Patients with extensive stage small cell lung cancer confirmed by imaging (staging according to the eighth edition of TNM staging);
• With measurable lesions (according to RECIST 1.1 standards, the long diameter of the tumor lesion on CT scan is ≥ 10mm);
• Need to have failed standard first-line treatment before enrollment;
• Agree to collect tumor histological specimens required for this study and use them in related research;
• Main organ function is normal, without severe abnormal blood, heart, lung, liver, kidney function and immunodeficiency diseases.
• Female subjects of childbearing potential must undergo a serum or urine pregnancy test within 72 hours before starting the trial drug, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive method (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 90 days after the last administration of the trial drug; male subjects whose partners are female subjects of childbearing potential should be surgically sterilized or agree to use effective contraceptive methods during the study and within 90 days after the last administration of the trial drug.
• Subjects voluntarily join this study and sign the Informed Consent Form (ICF), have good compliance, and can follow up the efficacy and adverse reactions as required by the protocol