lung cancer
Conditions
Interventions
Experimental group:Induction treatment period (4 cycles, 21 days a cycle) : vorolanib initiator 100 mg QD, after enrolling 3 patients without SAE, add to 200mg QD
Cisplatin 75 mg/m2 d1-3,and Etoposide 100 mg/m2 d1-3 were given intravenously.
Maintenance treatment period: vorolanib 200MG/d, oral, until the disease progression.
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically confirmed ES-SCLC disease (according to the Veterans Administration Lung Study Group, VALG staging) ; 2)No prior systemic treatment for ES-SCLC; 3)Patients who have received radiotherapy and chemotherapy for limited SCLC in the past must have received radical treatment, there was at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (the end time of the last chemotherapy cycle/the end time of the last radiotherapy) ; 4)Measurable lesions defined by the RECIST 1.1 criteria exist, and a previously irradiated lesion can be considered a measurable lesion only if it appears after radiotherapy, has definite progression, and if that previously irradiated lesion is not the only lesion; 5)Age:18-75; 6)ECOG performance status: 0-1. ; 7)Expected survival time >3 months.; 8)Normal function of major organs.
Exclusion criteria
Exclusion criteria: 1)Previous use of antiangiogenic drugs such as anlotinib, Apatinib, bevacizumab or related immunotherapy drugs such as PD-1, PD-L1; 2)Subjects with known central nervous system metastases Andor carcinomatous meningitis; 3)Unless asymptomatic or treated and stable, there is no imaging evidence of new or enlarged brain metastases at least 2 weeks after treatment, she stopped steroid or Anticonvulsant therapy for at least 14 days before starting the study. If active or new untreated, asymptomatic CNS metastases are found on imaging during the screening period, patients must be treated with or without radiotherapy, but no new or enlarged brain metastases were found for at least 2 weeks; 4)Within 5 years, the subjects had previous or concurrent malignancies (except for cured skin basal-cell carcinoma and cervical carcinoma in situ) ; 5)Having multiple factors affecting oral medication (such as inability to swallow, post-gastrectomy, chronic diarrhea, and intestinal obstruction) ; 6)Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 7)Surgery and/or radiotherapy failed to cure or relieve spinal cord compression, or previously diagnosed spinal cord compression after treatment without clinical evidence of disease stabilization for =1 week before randomization; 8)Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from the great vessels; 9)Subjects with evidence or a history of bleeding tendency, regardless of severity, within 2 months before the first dose, hemoptysis (defined as a history of bright red or 1/2 teaspoon of blood, or the presence of an unhealed wound, ulcer, or fracture; 10)Subjects with prior treatment-induced adverse events (except alopecia) that did not return to = CTCAE grade 1; 11)Major surgical treatment or significant traumatic injury was performed within 28 days before randomization; 12)History of AVT events, such as cerebrovascular accident (including transient ischemic attack) , thrombosis and pulmonary embolism, within 6 months before randomization; 13)Having a history of psychotropic substance abuse and unable to quit or having mental disorders; 14)Subjects with any severe and/or uncontrolled disease included: a)Subjects with suboptimal blood pressure control (systolic blood pressure =150 mm Hg or diastolic blood pressure =100 mm Hg) ; b)Patients with =2 grade myocardial ischemia or myocardial infarction, arrhythmia; c)Active or uncontrolled severe infection (= CTCAE Grade 2 infection) ; d)Cirrhosis, active hepatitis * ; * active hepatitis (Hepatitis B Reference: HBsAg positive with HBV DNA detected above upper limit of normal; hepatitis C Reference: HCV antibody positive with HCV viral titer detected above upper limit of normal) ; e)HIV positive; f)Poor control of diabetes (FBG > 10mmol/L) ; g)Urine routine indicated proteinuria=++, and confirmed that 24-hour proteinuria was more than 1.0 g; h)Vaccinated with prophylactic or attenuated vaccine within 4 weeks before the first dose; i)Severe hypersensitivity to other monoclonal antibody; j)Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, corticosteroid, or immunosuppressants) occurring within 2 years before the first dose (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring Bronchodilator medical intervention was not included) . Replacement therapy (e.g. thyroid hormone, insulin, or ph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month OS rate;Dose Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Progression-free survival-2;Overall survival;Duration of Response;6-month PFS rate;12-month PFS rate; | — |
Countries
China
Contacts
Public ContactDiansheng Zhong
Tianjin Medical University General Hospital
Outcome results
None listed