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Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.
This exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | In this study, patients will receive concurrent hyperfractionated accelerated radiotherapy (HART) combined with chemotherapy for 4 cycles. If patients achieve a complete response (CR) or partial response (PR) after the initial treatment, they will be given prophylactic cranial irradiation (PCI). Following PCI, patients will enter the maintenance treatment phase with Adebrelimab, which will continue until disease progression, death, or the development of intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy | Drug | Chemotherapy: Etoposide will be administered intravenously at a dose of 100 mg/m² on days 1 to 3 of each cycle. Cisplatin will be given at a dose of 75 mg/m² on day 1 of each cycle. The treatment will be repeated every 3 weeks for a total of 4 cycles. Concurrent Radiotherapy: Chest radiotherapy will be initiated concurrently with the first 3 cycles of chemotherapy. The total dose of radiotherapy will be 54 Gy, delivered in 30 fractions, with 2 fractions per day. Prophylactic Cranial Irradiation (PCI): For patients who achieve a partial response (PR) or complete response (CR) after chemoradiotherapy, PCI will be administered 3 to 4 weeks after the completion of chemoradiotherapy. The dose for PCI will be 25 Gy in 10 fractions. Adebrelimab Maintenance Therapy: Following PCI, patients will receive maintenance therapy with Adebrelimab. The dose will be 1200 mg administered intravenously on day 1 of each cycle. The treatment will be repeated every 3 weeks until disease progression, death |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events | Treatment-related adverse events according to CTCAE 5.0 | Duration of treatment and follow up until death or 90 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | From the date of enrollment to the date of disease progression | From enrollment to the end of treatment at 1 and 2 year |
| OS | from the date of enrollment until death by any cause or last follow-up |
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Inclusion Criteria:
Normal function of major organs, which means meeting the following criteria:
Complete blood count:
Hemoglobin (HGB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; White blood cell count (WBC) ≥3.0×10⁹/L;
Biochemical tests:
Serum albumin (ALB) ≥30 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; this does not apply to patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia [mainly unconjugated bilirubin], without evidence of hemolysis or liver pathology). After consultation with a physician, patients with this condition may be allowed to participate in the study.
Exclusion Criteria:
Patients with vitiligo or alopecia;
Previously diagnosed with any other malignancy, except for the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AnHui Shi, MD | Contact | 139 0113 6511 | anhuidoctor@163.com | |
| JiaYi Yu, MD | Contact | 18518362213 | yujiayi0323@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital and Institute | Beijing | Beijing Municipality | 100142 | China |
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| From date of enrollment to maximum of 2 years or death |
| ORR | The proportion of subjects with Best Overall Response (BOR) assessed as Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria | From date of enrollment to maximum of 2 years |
| DCR | DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1. | From date of enrollment to maximum of 2 years |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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