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To evaluates the effectiveness and safety of Toripalimab combined with Anlotinib and chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Toripalimab combined with Anlotinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab Combined With Anlotinib, Etoposide and Platinum | Experimental | Toripalimab 240mg,d1,q3w+Anlotinib 12mg/d,d1-14,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 or Carboplatin AUC=5, d1, q3w,4-6 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Toripalimab 240mg,d1,q3w+Anlotinib 12mg/d, was taken orally for 2 weeks and stopped for 1 week until the disease progressed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab 240mg,ivgtt,d1,q3w. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Defined as the time interval from randomization to death. If the patient continues to survive or his life or death is unknown, the date of death will be reviewed using the latest point in time when the patient is still alive. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | It is defined as the number of cases achieving CR, or PR, as a percentage of patients with evaluable efficacy. Disease remission and progress will be evaluated based on RECIST standards. | up to 2 years |
| Disease control rate(DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment | up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wang, PH.D | Contact | 86-23-68757181 | dongwang64@hotmail.com | |
| Dong Wang, PH.D | Contact | 13678428206 | dongwang64@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wang, PH.D | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| Anlotinib | Drug | Anlotinib 12 mg/d,d1-14,q3w,4-6 cycles in total. In maintenance treatment period, Anlotinib 12 mg/d,d1,Oral for 2 weeks and stop for 1 week. |
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| Cisplatin | Drug | 75mg/m2,d1,q3w,4-6 cycles in total. |
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| Carboplatin | Drug | AUC=5,d1,q3w,4-6 cycles in total. |
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The percentage of cases that achieved remission (PR+CR) and stable disease (SD) after treatment accounted for the number of evaluable cases. In short, DCR=CR+PR+SD. And the RECIST standard is to maintain at least 4 weeks. |
| up to 2 years |
| Progress Free Survival(PFS) | It is defined as the time interval from randomization of patients to disease progression or death, whichever comes first. There was no progress or the time of disease progression was not recorded when the trial was withdrawn, and the date of the last examination was used as the end date. | up to 2 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C000625192 | anlotinib |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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