Immunotherapy, Personalized Cancer Treatment, Radiotherapy, Small Cell Lung Cancer ( SCLC )
Conditions
Keywords
Small Cell Lung Cancer (SCLC), Radiotherapy, Immunotherapy, Personalized Cancer Treatment
Brief summary
By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.
Interventions
RADIATIONradiatherapy, and chemotherapy with or without immunotherapy as clinical practice
This is an observation study. This study adopted different timing of radio-immunotherapy combination, fractionation schedules, radiation doses, irradiation sites, PCI, and various types of immune checkpoint inhibitors.
Sponsors
Shanghai Chest Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC): 1\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system). 3\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria. 8\. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments): 1. Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L. 2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L. 3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range). 9\. Pulmonary function test showing FEV₁ \> 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET/CT prior to treatment. 11\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. Inclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): 1\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system). 3\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments): 1. Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L. 2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L. 3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range). 8\. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) \> 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions. 11\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 12 months after the last participant entry | The time from the start of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. |
| Overall Survival (OS) | up to 12 months after the last participant entry | The time from the start of study treatment to death from any cause or the data cut-off date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Metastasis-Free Survival | up to 12 months after the last participant entry | the time from the date of diagnosis to the first occurrence of distant metastasis. For patients with extensive-stage small cell lung cancer (ES-SCLC) who already have distant metastasis at baseline, DMFS is defined as the time to new distant organ metastasis or new distant lesions. Patients who have not developed distant metastasis by the last follow-up are censored. |
| Locoregional Recurrence-Free Survival (LRFS) | up to 12 months after the last participant entry | The time from the date of diagnosis to the first locoregional disease progression. Patients who have not experienced locoregional events by the last follow-up are censored. |
| Objective Response Rate (ORR) | up to 12 months after the last participant entry | The percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) during the study period. The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record). |
| Disease Control Rate (DCR) | up to 12 months after the last participant entry | The percentage of patients achieving a best overall response of CR, PR, or stable disease (SD). The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record). |
| Local Control Rate (LCR) | up to 12 months after the last participant entry | The start of radiotherapy to the first objective progression within the irradiated target volume, or death, or the last follow-up date. |
Countries
China
Contacts
CONTACTXuwei Cai, Ph.D
Outcome results
None listed