Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:VC: Intravenous injection. One treatment cycle lasts for 7 days. Administration on days 1 to 3 (1.5g /kg/ day), with each administration lasting for 3 hours (the maximum infusion ra
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. At the time of signing the informed consent form, the age should be no less than 18 years old, with no gender restrictions. 3. Platinum-based dual-drug chemotherapy is not suitable for the following reasons: ECOG PS of 2-3, or age >=70 years old, with severe comorbidities or contraindications to chemotherapy; If the ECOG PS is 0-1 and the researcher assesses that the subject is suitable for platinum-based chemotherapy, but the subject refuses chemotherapy, they can also be enrolled. 4. No variations in driver genes such as EGFR, ALK, ROS1, and RET; 5. The expected survival period is no less than 8 weeks; 6. Male and female patients of childbearing age all agreed to use reliable contraceptive methods before entering the trial, during the study process, and within 8 weeks after drug withdrawal. 7. According to the solid tumor efficacy evaluation criteria RECIST 1.1, there is at least one measurable lesion; 8. Histologically or cell-confirmed, locally advanced or metastatic stage IIIB/IIIC/IV NSCLC (according to the ninth Edition of the TNM staging system of the American Joint Committee on Cancer); 9. Wild type of KEAP1 gene; 10. Allow newly diagnosed or previously treated patients who have received systemic anti-tumor therapy to be enrolled in the group; 11. Allow patients with asymptomatic brain metastases to be enrolled; Women of childbearing age (15 to 49 years old) must undergo a urine pregnancy test within 7 days before the start of treatment and the result must be negative. 13. Normal functions of major organs should meet the following criteria: • Blood routine test criteria (no blood transfusion or blood products within 14 days, and no correction using G-CSF and other hematopoietic stimulating factors) : Hemoglobin (HB) >=90g/L b) The absolute value of neutrophils (ANC) is >=1.5×10^9/L c) Platelet count (PLT) >=80×10^9/L; Biochemical tests must meet the following indicators: a) Total bilirubin (TBIL) =50ml/min. For patients who have not received anticoagulant therapy, the International normalized ratio of prothrombin time (INR) is less than or equal to 1.5, and the partial thromboplastin time (APTT) is less than or equal to 1.5 times the upper limit of the normal value. Patients who receive full-dose or parenteral anticoagulant drug treatment can enter clinical trials as long as the dosage of anticoagulant drugs is stable for at least 2 weeks before entering clinical research and the results of coagulation tests are within the range restricted by local treatment. • Urine protein <2+.
Exclusion criteria
Exclusion criteria: 1.Large cell carcinoma and mixed cell lung cancer 2. During screening and previous radiological imaging evaluations, active or untreated central nervous system metastases identified through computed tomography (CT) or magnetic resonance imaging (MRI) assessment; 3. Uncontrolled tumor-related pain; 4. Have a history of kidney stones; 5. Currently, vitamin K antagonists are used for treatment; 6. Uncontrolled pleural effusion, pericardial effusion or ascites requires repeated drainage operations (once a month or more frequently); 7. Severe hypercalcemia (serum calcium > 3.5 mmol/L); 8. Patients with cancers other than NSCLC within five years prior to the start of treatment in this study. Excluding cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis]; Patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency 10. Patients allergic to vitamin C; 11. Patients with multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 12. Patients with any severe and/or uncontrolled diseases, including: a) Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); b) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc>=480ms) and grade >=2 congestive heart failure (NYHA classification); c) Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), with a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; Note: Under the premise that the International normalized ratio of prothrombin time (INR) is less than or equal to 1.5, low-dose heparin (daily dosage for adults is 6,000 to 12,000 U) or low-dose aspirin (daily dosage is less than or equal to 100 mg) may be used for preventive purposes. d) Active or uncontrolled severe infection; e) Antiviral treatment is required for liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; f) Renal failure requires hemodialysis or peritoneal dialysis; g) Those with a history of immune deficiency, including those who are HIV positive or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; h) Poor control of diabetes (fasting blood glucose (FBG) > 10 mmol/L); i) Urine routine test indicates urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is > 1.0g; j) Patients with epileptic seizures who require treatment; k) Long-term unhealed wounds or fractures, etc. 1) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) occurred within 2 weeks before enrollment; Or significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or suffering from phlebitis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Duration of relief;Objective response rate;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactTian Panwen
West China Hospital of Sichuan University
Outcome results
None listed