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| ID | Type | Description | Link |
|---|---|---|---|
| 2024 Review (No. 1573) | Other Identifier | Biomedical Ethics Review Committee of West China Hospital of Sichuan University |
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| Name | Class |
|---|---|
| Shanghai Shengdi Pharmaceutical Co., Ltd | INDUSTRY |
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Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Adebrelimab combined with chemotherapy synchronous LDRT |
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| Group B | Active Comparator | Adebrelimab combined with chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab combined with chemotherapy synchronous LDRT |
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Time from randomization to death from any cause. Unit of measure: median overall survival (months); hazard ratio (HR) and 95% confidence interval (CI); 12- and 24-month survival rates (%). Assessment schedule: survival status assessed every 3 months after the end of treatment until death or study cut-off (up to 36 months). | From date of randomization to the time when the subject died from any cause, up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time from randomization to the earliest of radiologically documented progressive disease (per RECIST 1.1 assessed by the investigator) or death from any cause. Unit of measure: median progression-free survival (months); hazard ratio (HR) and 95% confidence interval (CI); 6- and 12-month PFS rate (%). Measurement tool: contrast-enhanced CT or MRI scanned every 6 weeks for the first 48 weeks, then every 12 weeks until disease progression, death, or study cut-off. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of PD-L1 expression with overall survival | Pearson correlation coefficient between baseline PD-L1 expression and overall survival (months). Unit of measure: r (dimensionless) with 95% confidence interval. Measurement tool: PD-L1 IHC 22C3 pharmDx assay; PD-L1 tumor proportion score (TPS, %). Assessment schedule: baseline diagnostic biopsy and, if clinically feasible, at the time of first and second tumor progression. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Lu | Contact | 02885424619 | radyoulu@hotmail.com | |
| Zhuoran Yao, M.D. | Contact | yaozhuoran@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| You Lu | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Sichuan | China |
The survival data of individual participant will be shared after the research is completed.
After the study is completed.
Other Medical Professionals with permission from Principle Investigator
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| Chemotherapy | Drug | Chemotherapy |
|
| low dose radiotherapy | Radiation | low dose radiotherapy |
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| From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months. |
| Time to second progression or death (PFS2) | Defined as time from randomization to the earliest of radiologically documented second progression (per RECIST 1.1 assessed by the investigator ) or death from any cause. Unit of measure: median PFS2 (months); hazard ratio (HR) and 95% CI; 6- and 12-month PFS2 rate (%). Measurement tool: contrast-enhanced CT/MRI. Assessment schedule: imaging every 6 weeks during induction; every 4-6 weeks during maintenance; after first PD, every 6 weeks until second PD or death. | From date of randomization to the date of second documented progression or death from any cause, whichever occurs first, assessed up to 36 months |
| Disease control rate | Proportion of randomized subjects with best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months. | From date of randomization until disease progression, death, or 24 months, whichever occurs first. |
| Overall response rate (ORR) | Proportion of randomized subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks (±7 days) for the first 48 weeks, then every 12 weeks (±7 days) until progression, death, or 36 months; response determined by site investigator. | From date of randomization until disease progression, death, or 24 months, whichever occurs first |
| Duration of response (DoR) | Time from first documented complete response (CR) or partial response (PR) per RECIST 1.1 (investigator assessment) until the date of documented progressive disease or death from any cause, whichever occurs first. Unit of measure: median duration of response (months); 95% confidence interval of the median; 6- and 12-month response duration rate (%) Assessment schedule: imaging every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months. | From the date of first CR/PR to the date of documented progression or death from any cause, assessed up to 36 months |
| Depth of Response | Maximum percentage reduction in the sum of longest diameters of target lesions relative to baseline per RECIST 1.1 assessed by the investigator. Unit of measure: median percentage change (%); inter-quartile range (IQR); Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months; tumor diameters measured by the site investigator. | From date of randomization until disease progression, death, or 24 months, whichever occurs first. |
| Post-progression survival (PPS) | Time from the date of first documented progressive disease (per RECIST 1.1, investigator assessment) to the date of death from any cause. Unit of measure: median post-progression survival (months); hazard ratio (HR) and 95% confidence interval; 6- and 12-month survival rate (%). Assessment schedule: survival status contacted every 3 months after progression until death, lost to follow-up, or study cut-off. | From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression. |
| Incidence and severity of adverse events (AEs) | Number and percentage of participants experiencing AEs graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%); number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug; assessed at every study visit (baseline, weekly during cycle 1, then day 1 of each subsequent cycle, and at follow-up). | Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases (to 90 days after the last dose of drug). |
| Incidence of serious adverse events (SAEs) | Number and percentage of participants experiencing serious adverse events (SAE) graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%) of subjects with ≥1 SAE; number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug. All SAEs reported within 24h of awareness. | Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases(before 2nd PD and 3 month afterwords). |
| From baseline to death from any cause, assessed up to 36 months |
| Correlation of PD-L1 expression with progression-free survival | Pearson correlation coefficient between baseline PD-L1 TPS and PFS (months). Unit of measure: r (dimensionless) with 95% CI. Measurement tool: PD-L1 IHC 22C3 pharmDx assay; TPS (%). Assessment schedule: baseline tumor biopsy. | From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months. |
| Correlation of neutrophil count with overall survival | Pearson correlation coefficient between baseline peripheral blood neutrophil count and overall survival (months). Unit of measure: r (dimensionless) with 95% CI. Measurement tool: automated hematology analyzer; absolute neutrophil count (10⁹/L). | From baseline to death from any cause, assessed up to 36 months |
| Patient-Reported Global Health Status and Quality of Life Score | Change in patient-reported global health status/quality of life score, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life scale (items 29 and 30). Unit of measure: Mean change from baseline in score. Scale Details: The EORTC QLQ-C30 global health status/QoL scale is a 7-point Likert scale ranging from 1 ("Very poor") to 7 ("Excellent"). The raw score is linearly transformed to a 0-100 scale. Higher scores indicate a better quality of life. | From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy, assessed up to 36 months |
| Patient-Reported Functioning Scale Scores (Composite of Five Scales) | Change in patient-reported functioning, as measured by the five functioning scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. Unit of Measure: Mean change from baseline in score for each scale. Scale Details: Each EORTC QLQ-C30 functioning scale consists of multiple items using a 4-point Likert scale (1="Not at all", 4="Very much"). Raw scores are linearly transformed to a 0-100 scale. For functioning scales, higher scores indicate a better level of functioning. | From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months. |
| Patient-Reported Lung Cancer Symptom Scale Scores (Composite of Scales) | Change in patient-reported lung cancer symptoms, as measured by the symptom scales and items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): dyspnoea, cough, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, and pain. Unit of Measure: Mean change from baseline in score for each symptom scale/item. Scale Details: EORTC QLQ-LC13 scales use a 4-point Likert scale (1="Not at all", 4="Very much"), transformed to a 0-100 scale. For symptom scales, higher scores indicate a greater severity of symptoms/worse outcome. | From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months. |
| OS in liver-metastasis subgroup | Treatment effect (adebrelimab + chemotherapy ± LDRT vs control) on overall survival in the pre-specified subgroup defined by baseline liver metastasis (yes vs no). Unit of measure: hazard ratio (HR) with 95% confidence interval; median overall survival (months); 12-month survival rate (%). Measurement tool: death from any cause determined by medical records or death registry. | From date of randomization to death from any cause, assessed up to 36 months |
| OS in brain-metastasis subgroup | Treatment effect on overall survival in the subgroup defined by baseline brain metastasis (yes vs no). Unit of measure: HR with 95% CI; median OS (months); 12-month survival rate (%). Measurement tool: death from any cause determined by medical records or death registry. | From date of randomization to death from any cause, assessed up to 36 months. |
| PFS in liver-metastasis subgroup | Treatment effect on PFS (RECIST 1.1, investigator) in the liver-metastasis subgroup (yes vs no). Unit of measure: HR with 95% CI; median PFS (months); 6-month PFS rate (%). Measurement tool: CT/MRI. | From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months. |
| PFS in brain-metastasis subgroup | Treatment effect on PFS in the brain-metastasis subgroup (yes vs no). Unit of measure: HR with 95% CI; median PFS (months); 6-month PFS rate (%). Measurement tool: CT/MRI. | From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months. |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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