lung cance
Conditions
Interventions
Experimental group:Alotinib
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration lung study group, valg stage) and advanced non-small cell lung cancer (NSCLC); 2.Previously received systemic therapy including arotinib; 3.At least one systematic treatment without anlotinib is needed before this treatment; 4.A measurable lesion defined by RECIST 1.1 standard can be considered only when a previously irradiated lesion has a clear progression after radiotherapy, and the previously irradiated lesion is not the only lesion; 5.Older than 18 years old; ECoG physical condition: 0-3 points; The expected survival time is more than 3 months; 6.The main organ function was normal, which met the following criteria: (1)Blood routine examination (no blood transfusion within 14 days, no use of hematopoietic stimulating factor drugs to correct the state): hemoglobin (HB) >= 90g / L; Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L; Platelet count (PLT)>= 100 x 10^9 /L WBC >= 3.0 x 10^9 /L ; (2)Biochemical examination: ALT and AST = 50ml / min; (3)Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%; 7.Women of childbearing age should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptive or condom) during the study period and within 6 months after the end of the study; The serum pregnancy test was negative within 7 days before the study was enrolled and must be non lactating subjects; Men should agree to use contraception during the study period and within 6 months after the end of the study period; 8.The subjects volunteered to join the study and signed informed consent, with good compliance.
Exclusion criteria
Exclusion criteria: 1.Subjects with known central nervous system metastasis and / or cancerous meningitis( Unless asymptomatic or treated and stable, no new brain metastases or enlarged brain metastases were found at least 2 weeks after the treatment, and steroid or anticonvulsant therapy was stopped for at least 14 days before the start of the study. If active or new untreated or asymptomatic CNS metastases are found in the screening period, the subjects must receive radiotherapy or no treatment, but no new brain metastases or enlarged brain metastases are found in at least 2 weeks.); 2.Within 5 years, the subjects had or had other malignant tumors (except the cured basal cell carcinoma of skin and carcinoma in situ of cervix); 3.Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.) that affect oral medication; 4.Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5.There was no clinical evidence that the disease was stable for more than 1 week before randomization for spinal cord compression that could not be cured or relieved by surgery and / or radiotherapy, or for previously diagnosed spinal cord compression after treatment; 6.Imaging (CT or MRI) showed that the tumor invaded the great vessels or the boundary between the tumor and the great vessels was unclear; 7.Subjects with evidence of bleeding tendency or history within 2 months before the first administration, regardless of severity; There was a history of hemoptysis (defined as bright red blood or 1 / 2 teaspoon) or unhealed wound, ulcer or fracture within 2 weeks before the first medication; 8.Subjects whose adverse events (except alopecia) caused by previous treatment did not return to CTCAE level 1 or less; 9.Major surgical treatment or obvious traumatic injury was performed within 28 days before randomization; 10.In the first 6 months of randomization, there were arteriovenous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 11.Have a history of psychotropic drug abuse and can not quit or have mental disorders; 12.Subjects with any severe and / or uncontrolled disease included: (1)Subjects with poor blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); (2)Patients with >= 2 grade myocardial ischemia or myocardial infarction, arrhythmia (including male with QTc >= 450ms (male), QTc >= 470ms (female)) and >= 2 grade congestive heart failure (NYHA classification); (3)Active or uncontrolled severe infection (>= CTC AE grade 2 infection); (4)Cirrhosis, active hepatitis *; * Active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV antibody was positive, and HCV titer detection value exceeded the upper limit of normal value); (5)HIV positive; (6)Poor control of diabetes mellitus (FBG > 10mmol / L); (7)Urine routine examination showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0 g; 13.Vaccinated with prophylactic vaccine or attenuated vaccine within 4 weeks before the first administration; 14.Participated in other clinical trials within four weeks; 15.According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of the subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;duration of remission;life quality score;exploratory goal;abnormal laboratory test indicators;adverse event;serious adverse event; | — |
Countries
China
Contacts
Public ContactJi Yinghua
The First Affiliated Hospital of Xinxiang Medical College
Outcome results
None listed