This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
The age range was 18 to 75 years, with no gender restriction.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
Parallel
Tislelizumab
Drugadministered via Intravenous (IV) injection
Carboplatin injection
Drugadministered via IV injection
Cisplatin injection
Drugadministered via IV injection
Etoposide injection
Drugadministered via IV injection
Pathologic Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Major Pathologic Response (MPR) Rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Event-Free Survival (EFS)
EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause.
Objective response rate (ORR)
The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
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This trial is not recruiting at the moment. You can still explore other options:
