advanced non-small cell lung cancer
Conditions
Interventions
intervention group:Hypofractionated radiotherapy+Sintilimab+bevacizumab +pemetrexed
control group:Sintilimab+bevacizumab +pemetrexed+Cisplatin
Sponsors
Department of Oncology, Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically demonstrated patients with advanced and metastatic non-squamous NSCLC with definite stages, such as chest or abdominal enhanced CT, head MRI, PET-CT/ whole body bone imaging; 2.patients aged 18 to 75 years old were able to give informed consent and sign informed consent, and were able to comply with the study protocol and follow-up procedure; 3. progress after treatment with EGFR-TKI. Disease progression is defined as acceptance of first or second or third generation EGFR-TKI progression, where the first or second generation EGFR-TKI requires confirmation of EGFR T790M negative mutations. 4.Life expectancy greater than 6 months; 5. American Eastern Cancer Cooperative Group ECOG score 0-2; 6.willing to provide tissue and blood samples from tumor lesions; 7.Adequate pulmonary function, required: first second forced breathing volume (FEV1) =1.2 l/s or =50% of predicted value, postoperative expectation (FEV1) = 30%; 8.No previous history of other lung malignancies, no chemotherapy or radiotherapy or antivascular therapy for lung tumors; 9.have a measurable lesion as defined by RECIST1.1, at least one lesion accurately measured by CT or PET/CT or MRI at baseline (never previously received radiation therapy) showing a maximum diameter of =10mm (except for lymph nodes, whose short axis must be =15 mm) and the lesion is suitable for repeated and accurate measurement; 10.patients who received hormone therapy more than 4 weeks ago and all adverse events from prior therapy have returned to = grade I (CTCAE 4.0); 11.The following laboratory tests performed within 7 days prior to the first dose confirmed that the patient met the study requirements for bone marrow, liver and kidney function: hemoglobin =9.0 g/dL (this level can be maintained or exceeded by transfusion); Red blood cell count =2.0×10^9/L Absolute neutrophil count (ANC) =1.0× 10^9/L; Platelet count =90×10^9/L; Total bilirubin =2.0 times the upper limit of normal value; Glutamic pyruvic transaminase, glutamic oxalacetic transaminase, alkaline phosphatase =2.5 times the upper limit of normal value; Creatinine =2.0 mg/dL Creatinine clearance =60ml/min; The International normalized ratio of prothrombin time (INR)=1.5 and partial thromboplastin time (APTT)=1.5 times the upper limit of normal for patients who did not receive anticoagulant therapy. Patients receiving full or parenteral anticoagulant therapy could be enrolled as long as the anticoagulant dose was stable for at least 2 weeks before entering the clinical study and coagulation function was within the limits of local treatment. Laboratory test values for the rest of the screening must meet the relevant standards; 12. Urine and serum HCG tests should be negative for women of childbearing age within 7 days before the start of treatment; Eligible men and women must use a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug. Reliable methods of contraception will be determined by the principal investigator or designated person. 13. Voluntarily participate in the study, fully understand and know about the study and sign the informed consent, willing to follow and have the ability to complete all test evaluation items.
Exclusion criteria
Exclusion criteria: 1.Histological or cytopathological diagnosis of small cell lung cancer or squamous cell carcinoma; 2.Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pecina, onset of angina within the last 3 months, congestive heart failure (= New York Heart Association Class II), heart infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease; 3.patients with uncontrolled neuropathy (grade 2 or above) or psychosis; Have an active, known or suspected autoimmune disease; Subjects with the following conditions may be enrolled: vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis; 4. Those who have previously failed or progressed after treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibody that acts on T-cell co-stimulation or checkpoint pathways); 5.chest X-ray examination, sputum examination, and nucleic acid-PCR considered active pulmonary tuberculosis; A history of active tuberculosis treatment within 1 year; The patients with more than 1 year history of active pulmonary tuberculosis were controlled for more than 1 year and the efficacy of anti-tuberculosis treatment was positive. 6. A known human history of testing positive for HIV or a known history of acquired immune deficiency syndrome (AIDS); If the first-line standard treatment is ineffective, the patients can be enrolled after full communication and clear death risk. 7.comorbidities requiring treatment with immunosuppressive drugs or systemic or local use of corticosteroids at immunosuppressive doses; 8.had previously received thoracic region radiotherapy and was assessed not to undergo further large segment radiotherapy; 9.Pregnant or breastfeeding women, and men and women who refuse to use appropriate contraceptive methods; 10. Patients who have had major surgery or severe trauma within 2 months before the first dose; 11.Has previously received or expects to have had an organ or bone marrow transplant during the study period; 12. Patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia or severe impairment of lung function; 13. Allergies to study medications. 14.conditions deemed unsuitable for inclusion by other researchers in a comprehensive assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Progression-free survival at 6 months;Progression-free survival at 12 months;Overall survival, OS;Safety and toxicity; | — |
Countries
China
Contacts
Public ContactLin Sheng
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed