This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.
Age between 18 and 75 years old;
Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0).
All lesions of the patient (including the primary lesion, lymph nodes/lesions assessed as metastatic) must be jointly evaluated and confirmed as resectable by a surgeon, a radiation oncologist, and a radiologist;
The subject must have measurable target lesions (according to RECIST 1.1 criteria);
Inability to completely remove all lesions through surgery;
Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion area).
Previously used immunocheckpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
Any history of active autoimmune diseases or autoimmune diseases (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); patients with childhood asthma that has completely resolved and does not require any intervention in adulthood or vitiligo can be included, but patients requiring medical intervention with bronchodilators are not eligible for inclusion;
Jin Ying
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution