lung cancer
Conditions
Interventions
Treatment group:Docetaxel combined with anlotinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age ranges from 18 to 75 years old; 2) ECOG performance status (PS) 0 ~ 1 score; 3) The expected survival is not less than 12 weeks; 4) Pathological diagnosis of stage IV non-small cell lung cancer with measurable lesions (according to the RECIST 1.1 standard, the length of CT scan for tumor lesions =10mm, the short diameter of CT scan for lymph node lesions =15mm, and the lesions can be measured without local treatment such as radiotherapy or freezing); 5) Patients who received first-line immunization combined with platinum-containing chemotherapy failed; Note: The treatment used in the neoadjuvant therapy phase is not included in the treatment regimen; If the patient relapsed within 6 months after the end of adjuvant therapy, the adjuvant therapy part was defined as first-line therapy; For recurrence over 6 months, adjuvant therapy is not included in the treatment program 6) Patients who had previously received radiotherapy could be enrolled, but the radiotherapy area had to be <25% of the bone marrow area (Cristy and Eckerman 1987) and had not been exposed to full pelvic or chest radiation; Prior radiotherapy must have ended for at least 4 weeks at the time of study enrollment, and acute toxic effects from prior radiotherapy must have recovered. Local lesions that have been treated with radiotherapy cannot be included in measurable lesions unless significant progression of the lesion is recorded after the last radiotherapy. 7)Major organ function is normal, that is, meet the following criteria: ? Blood routine examination criteria should meet: a) ANC=1.5×10^9/L; b) PLT=100×10^9/L; c) Hb=90g/L; (No blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors) ? Biochemical examination should meet the following standards: a) TBIL < 1.5×ULN; b) ALT and AST < 2.5×ULN, for patients with liver metastasis, ALT and AST<5×ULN; c) BUN and Cr = 1 × ULN or endogenous creatinine clearance = 60ml/min (Cockcroft-Gault formula); 8) Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last dose of the trial drug; 9)The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1)Small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer); 2) symptomatic brain metastases (patients with brain metastases who had completed treatment 21 days before enrollment and had stable symptoms could be enrolled, but no symptoms of cerebral hemorrhage were confirmed by brain MRI, CT or venography evaluation); 3) Imaging (CT or MRI) shows that the tumor lesion is less than 5 mm away from the major blood vessels, or there is a central tumor that invades the local major blood vessels; Or the presence of significant pulmonary cavity or necrotic tumor; 4) Patients with high blood pressure who are being treated with a combination of two or more antihypertensive drugs; 5) First-line treatment for patients receiving docetaxel chemotherapy; 6) Suffering from the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms for men and =470 ms for women); According to NYHA criteria, patients with grade ? to ? cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; 9) Daily hemoptysis of 2 teaspoons or more before enrollment; 10) There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis; 11) Arteriovenous thrombosis events occurring within 12 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 12) Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 13) Wounds or fractures that have not healed for a long time (pathological fractures due to tumors do not count); 14) Had major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 15)There are factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction 16)Abdominal fistula, gastrointestinal perforation or abdominal abscess in the 6 months prior to enrollment; 17)Urine routine indicates urine protein = ++, or confirms 24-hour urine protein volume = 1.0g; 18) Serosal effusion with clinical symptoms requiring symptomatic treatment (including pleural effusion, ascites, pericardial effusion) Note: Asymptomatic serous effusion can be included in the group, while symptomatic effusion can be treated with active symptomatic treatment (anti-cancer drugs cannot be used to treat serous effusion). Patients who are judged by researchers to be eligible for inclusion are allowed to be included. 19) Active infections requiring antimicrobial treatment (such as antibiotics, antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment, antifungal drug treatment); 20) Have a history of psychotropic drug abuse and can not quit or have mental disorders; 21) Participants who had participated in other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;TTPD;DOR;QoL; | — |
Countries
China
Contacts
Public ContactYun Fan
Zhejiang Cancer Hospital
Outcome results
None listed