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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
| First People's Hospital of Foshan | OTHER |
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The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab + CRT arm | Experimental | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. |
|
| CRT arm | Active Comparator | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS, measured from the date of randomization to the date of death from any cause. | 5 years |
| Overall response rates | ORR, tumor response will be measured by using the RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Chen, MD. PhD. | Contact | 86-571-88122199 | chenming@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Chen, MD. PhD. | Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital) | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Etoposide | Drug | Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66. |
|
|
| Cisplatin | Drug | cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64. |
|
|
| radiotherapy | Radiation | Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions). |
|
| 2 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |