limited-stage small-cell lung cancer
Conditions
Interventions
Experimental group:Concurrent treatment with triaxil during chemoradiotherapy and consolidation immunotherapy with envafolimab after chemoradiotherapy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed diagnosis of small-cell lung cancer (SCLC). 2.Radiologically confirmed limited-stage disease, defined as lesions confined to one hemithorax and within a single radiation field, without malignant pleural or pericardial effusion; at least one measurable lesion according to RECIST version 1.1. 3.Completion of two cycles of induction chemotherapy with etoposide plus cisplatin or carboplatin. 4.Age between 18 and 75 years, male or non-pregnant female. 5.Estimated life expectancy >3 months. 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 7.Body weight >30 kg. 8.All patients underwent baseline imaging, including chest CT, brain MRI, abdominal CT or MRI, and whole-body bone scan, prior to treatment to confirm disease extent. 9. Hematologic system indicators: White blood cell (WBC) count >= 4×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L, hemoglobin (Hb) level > 100 g/L, platelet (Plt) count > 100×10^9/L, serum creatinine (Cr) level < 1.5 times the upper limit of normal, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels < 2.5 times the upper limit of normal, serum bilirubin level <= 1.5 times the upper limit of normal. 10.Signed written informed consent prior to enrollment and willingness to comply with all study visits, treatment schedules, laboratory tests, and other protocol-specified procedures.
Exclusion criteria
Exclusion criteria: 1.Histopathological diagnosis of non–small-cell lung cancer (NSCLC) or small-cell lung cancer with mixed histologic components. 2.Diagnosis of extensive-stage small-cell lung cancer (ES-SCLC). 3.Presence of malignant pleural effusion or pericardial effusion. 4.Pregnant or breastfeeding women. 5.Patients with severe underlying diseases that may interfere with study treatment or safety assessment. 6.Prior treatment with immune checkpoint inhibitors, including CTLA-4, PD-1, or PD-L1 inhibitors. 7.Requirement for long-term immunosuppressive therapy, or concomitant conditions necessitating systemic or local corticosteroids at immunosuppressive doses. 8.History of autoimmune disease or organ transplantation, including but not limited to: interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, or hypothyroidism. Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible. Patients with asthma requiring bronchodilators or medical intervention are excluded. 9.Laboratory test results during the screening period that do not meet the required standards. 10.Patients with significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function. 11.Patients with severe or uncontrolled systemic disease or active infection. 12.Concurrent participation in another clinical trial or use of other investigational drugs. 13.Refusal or inability to provide written informed consent. 14.Known hypersensitivity or allergy to any component of the study drugs. 15.Any other condition judged by the investigator to make the patient unsuitable for participation or unlikely to comply with study procedures, restrictions, or requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Incidence of adverse events and serious adverse events;Duration of response (DOR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Overall survival (OS);Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactNan Bi
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed