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| Name | Class |
|---|---|
| Wuhan University | OTHER |
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A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar combined Radiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human endostatin (Endostar) | Drug | Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). | up to approximately 3 years |
| adverse events (AE) | Number of participants with adverse events as assessed by CTCAE v5.0 | 5 years from patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique. | up to 5 years from patient enrollment |
| Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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|
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| Thoracic irradiation of 50 Gy with 3DCRT or IMRT | Radiation | Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy. |
|
ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
| Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| C522911 | endostar protein |
| C000613593 | durvalumab |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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