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To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adaptive radiotherapy strategy | Experimental | After two cycles of sintilimab and platinum based chemotherapy, receive two additional courses of sintilimab and platinum based chemotherapy and adaptive radiotherapy strategy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug | Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Paclitaxel or Paclitaxel liposome 135-175mg/m2 D1 IV Q3W(Squamous) Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Pemetrexed, 500mg/m2 D1 IV Q3W(adenocarcinoma) Radiation:Adaptive radiotherapy with V20<20%: 1.PGTV60-66Gy/2.0-2.2Gy/30F;PTV54Gy/1.8Gy/30F;2.PGTV54-66Gy/2.0-2.2Gy/30F;3.PGTV50Gy/2.0Gy/25F |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause | 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | the rate of patients with PR and CR | 28 months |
| Disease Control Rate (DCR) | the rate of patients with PR and CR and SD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XueWen Liu | Contact | 0731-88638888 | 603263@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya 3rd Hospital, Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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|
| 28 months |
| Overall Survival (OS) | The time from the beginning of treatment to the time when the patient dies from any cause | 28 months |
| AE | Incidence of Treatment-Emergent Adverse Events | 28 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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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