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To evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib Combined With Toripalimab and Chemotherapy | Experimental |
| |
| Surufatinib Combined With Chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib,Etoposide,Cisplatin,Toripalimab | Drug | In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21,q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21,q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21,q3w+Toripalimab 240mg,d1,q3w was taken orally until the disease progressed. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival(PFS) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | up to 24 months | |
| Overall Survival(OS) | up to 24 months | |
| Disease control rate(DCR) |
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Inclusion Criteria:
Exclusion Criteria:
5.Cardiovascular disease history: congestive heart failure> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment (Allows to take beta blockers or digoxin); 6.Active severe clinical infections (>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive). Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative; 7.Patients with bleeding tendency or coagulation disorders, (14 days before randomization must meet: INR is within the normal range without the use of anticoagulants); 8.In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment); 9.Those who have received live vaccination within 4 weeks before the start of treatment; 10.Those who had suffered from tumors other than small cell lung cancer within 5 years before being enrolled in this study. Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor; 11.Severe unhealed wounds, ulcers or fractures; 12.Patients who are pregnant or breastfeeding ; 13.Any unstable conditions may endanger the safety of patients and affect their compliance with research; 14.Researchers think it is inappropriate to participate in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenfeng Fang, MD. | Contact | +86-15322302066 | fangwf@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39327433 | Derived | Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2. |
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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 |
|---|---|
| C000717729 | surufatinib |
| C075609 | PE regimen |
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|
| Surufatinib,Etoposide,Cisplatin | Drug | In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21,q3w was taken orally until the disease progressed. |
|
| up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |