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;
Single group
Adebrelimab
DrugThis product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
Apatinib Mesylate
DrugThis product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.
Etoposide
DrugThis product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).
Carboplatin
DrugThis product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).
EFS of 2 years
The proportion of patients who did not experience any of the following events from the start of treatment to 2 years: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.
MPR
MPR (Major Pathological response,) was defined as residual tumor cells ≤10% in pathological examination of postoperative specimens.
EFS
EFS (Event-Free Survival) refers to the time from the beginning of randomization to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.
OS
OS (Overall Survival), the time from the date of randomization until the death of the participant or the last follow-up.
ORR
ORR (Objective Response Rate) refers to the proportion of patients whose tumor shrinkage reaches a certain level and remains for a certain period of time, including complete response (CR) and partial response (PR) cases.
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Jin Ying
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution