Non-small cell lung cancer
Conditions
Interventions
Sponsors
Beijing Changli Chenghua Medical Clinic
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years; (2) Locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histopathology (Guidelines for Diagnosis and Treatment of Primary Lung Cancer (2018), Chinese Society of Clinical Oncology); (3) According to RECIST 1.1, at least one tumor can satisfy the following requirements: no previous local treatment such as radiotherapy, and no research screening biopsy (if there is only one target lesion and a tissue biopsy is required, screening biopsy should be performed for at least 14 days). Baseline tumors were assessed later and could be measured accurately at baseline. The longest diameter of baseline period was more than 10 mm (in the case of lymph nodes, the shortest diameter was more than 15 mm). The selected measurement method is suitable for accurate repetitive measurement, which can be computed tomography (CT) or magnetic resonance scanning (MRI). If only one measurable lesion exists, local treatment such as radiotherapy is required. (4) those with an expected survival of more than three months; (5) Those who have not received surgery or radiotherapy or chemotherapy; (6) Subjects volunteered to participate and sign written informed consent; (7) Within 7 days before the first medication, the results of serum or urine pregnancy test for women of childbearing age were negative. Male patients and women of childbearing age must take adequate contraceptive measures within three months from the signing of informed consent to the last drug treatment study.
Exclusion criteria
Exclusion criteria: (1) Those who have received radiotherapy and chemotherapy or lung cancer-related surgery in the past; (2) Patients with small cell lung cancer; (3) Brain metastasis with spinal cord compression or symptoms, asymptomatic, stable condition and no need of steroid therapy for more than 28 days before the start of research and treatment, except for patients who have received local radiotherapy for brain metastasis, the symptoms of brain metastasis can only be stable for 28 days or more after the end of radiotherapy. (4) suffering from other malignant tumors or the history of other malignant tumors; (5) Severe clinical abnormalities in gastrointestinal function may affect the intake, transport or absorption of research drugs, such as uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, recurrent diarrhea, atrophic gastritis (younger than 60 years of age), long-term use of PP without cure. Gastric diseases, Crohn's disease and ulcerative colitis with class I acid inhibitors; (6) Bone marrow reserve and insufficient function of liver and kidney organs reached the following laboratory values (no blood transfusion or blood products, no use of granulocyte colony stimulating factor or other hematopoietic stimulating factors corrected within 2 weeks before blood sampling in the group laboratory): (a) absolute value of neutrophils 1.5 * upper limit of normal value (ULN); total bilirubin > 3 *ULN if there is definite Gilbert syndrome (pulmonary-bound hyperbilirubinemia) or liver metastasis; E. Serum ALT and/or AST > 2.5 *ULN (both AST and/or ALT > 5 *ULN in patients with liver metastasis); f. Serum creatinine > 1.5 *ULN, or creatinine clearance 1.5, and Partial Activated Prothrombin Time (APTT) > 1.5*ULN; (7) Active infection of HBV, HCV or HIV; (8) Patients with severe cardiovascular and cerebrovascular diseases; (9) History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid therapy, or acute onset or progressive onset at baseline, and pulmonary symptoms considered unsuitable or high-risk factors judged as possible interstitial lung disease and unsuitable for enrollment; (10) Known or suspected allergies to research drugs and/or their excipients; (11) Female patients during pregnancy or lactation; (12) Researchers believe that patients have any disease or medical status that is unstable or may affect their safety or research compliance, such as uncontrolled hypertension, uncontrolled diabetes, active hemorrhagic constitution, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PECCT CT or MRI;survival status;stage of adenocarcinoma;blood routine;urine routine;liver and kidney function;electrocardiogram;death;surgical treatment;radiotherapy and chemotherapy;48 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| complications;patient demographic information;combination of drugs;lung cancer markers (CEA);squamous cell carcinoma associated antigen (SCC);cytokeratin 21-1 fragment (CYFRA21-1);cancer antigen 125 (CA125); | — |
Countries
China
Contacts
Public ContactChang Yongliang
Beijing Changli Chenghua Medical Clinic
Outcome results
None listed