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| ID | Type | Description | Link |
|---|---|---|---|
| CRTOG2501 | Other Identifier | CRTOG |
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To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab plus chemo and radiotherapy | Experimental | Experimental treatment
Control group: This study refers to the Phase III RATIONALE-312 study, the reported median PFS was 4.7 months in patients treated with Tislelizumab combined with chemotherapy. This regimen has been recommened as 1L treatment for ES-SCLC in the CSCO guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab, Carboplatin /Cisplatin, Etoposide | Drug | Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5fï¼› |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until PD or death, whichever occurs first or up to approximately 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1 | Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuanghu Yuan, PhD | Contact | 0551-62894008 | yuanshuanghu@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Recruiting | Hefei | Anhui | 230031 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Duration Of Response (DOR) | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1 | Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months |
| Disease Control Rate (DCR) | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1 | up to approximately 23 months |
| 6-moth/1-year Progression Free Survival (PFS) Rate | The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose. | up to approximately 23 months |
| 1-year Overall Survival (OS) rate | The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose. | up to approximately 23 months |
| Number Of Participants Experiencing Treatment-Emergent Adverse Events | Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events | up to approximately 23 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |