Lung cancer
Conditions
Interventions
experimental group 1:ENDOSTAR & AP
control group 1:AP
experimental group 2:ENDOSTAR & GP
control group 2:GP
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG performance status (PS) level 0~1; 3. The estimated lifetime is not less than 12 weeks; 4. Pathologically confirmed IIIB (not suitable for radiotherapy), stage IV lung adenocarcinoma, lung squamous cell carcinoma patients, with measurable lesions (according to RECIST 1.1, CT scan long diameter >=10mm, lymph node lesion CT scan short The diameter is >=15mm, and the lesion can be measured without receiving local treatment such as radiotherapy or freezing); 5. Previously did not receive chemotherapy or other vascular epidermal growth factor (VEGF) pathway inhibitors; (Note: The treatment used in the neoadjuvant treatment phase is not included in the treatment plan; the recurrence within 6 months after the end of adjuvant therapy is defined as first-line treatment and cannot be included in the study. To patients who recur more than 6 months, adjuvant therapy is not included in the treatment plan); 6. Negative driving genes; 7. Patients who have previously received radiation therapy can be enrolled, but the radiotherapy area must be =1.5x10^9/L; PLT >=100x10^9/L; Hb>=100g/L; (No treatment of blood transfusion and blood product within 14 days, not corrected by G-CSF and other hematopoietic stimuli); (2) Biochemical examinations must meet the following criteria: TBIL =50ml/min (Cockcroft-Gault formula); 9. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days prior to the enrollment and the results should be negative, and willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the test drug. For men, consent must be given to appropriate contraceptive methods during the trial and 8 weeks after the last administration of the test drug or have experienced surgical sterilization; 10. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastasis (patients with brain metastases who have completed treatment and have stable symptoms for 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography that no cerebral hemorrhage symptom has occurred); 2. Imaging (CT or MRI) shows that the tumor lesion is =450 ms, women >=470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler examination revealed a left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) >ULN + 4 seconds or APTT >1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulant therapy; 7. Known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.); 8. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 9. Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment; 10. With or without other unhealed malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer; 11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures. Exit criteria: treatment shows intolerable toxicity for the patient or tumor progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;TTP;DoR;QoL;AE; | — |
Countries
China
Contacts
Public ContactJian Zhang
Zhujiang Hospital of Southern Medical University
Outcome results
None listed