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| ID | Type | Description | Link |
|---|---|---|---|
| HLX10IIT110 | Other Identifier | Guangdong Provincial People's Hospital |
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| Name | Class |
|---|---|
| Liaoning Cancer Hospital & Institute | OTHER |
| Guangzhou No.12 People's Hospital | OTHER_GOV |
| Second Xiangya Hospital of Central South University | OTHER |
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This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 cycles of Serplulima plus platinum-containing dual drug | Experimental | After 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin | Drug | After 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response rate | The proportion of residual tumor cells evaluated under the microscope by the pathologist | Within 2 weeks after radical surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Measured according to RECIST1.1 evaluation criteria | Once every 2 cycles(each cycle is 21 days) during the combined treatment phase |
| Event-free survival | Assess whether the lesion is operable and measure the progression of the lesion according to the RECIST1.1 assessment criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Huang, MD | Contact | +8616620159730 | jeromehuang1997@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Follow-up at the end of cycle 2(each cycle is 28 days), 3 to 5 weeks after the last chemotherapy, 30 days after surgery, every 3 months within two years from enrollment or until death |
| Overall survival | Lesions were measured according to RECIST1.1 evaluation criteria | Follow-up every 3 months and every 6 months within two years from enrollment or until death |
| ID | Term |
|---|---|
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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