Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:AI-Assisted Zhishan Formula: For newly diagnosed patients, a fixed traditional Chinese medicine (TCM) prescription formulated by integrating AI large model technology calculations w
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible patients must satisfy all the following inclusion criteria to be enrolled in this study: (1)Patients who voluntarily participate in this study and provide written informed consent; (2)Histologically or cytologically confirmed stage IV non-small cell lung cancer (NSCLC) with measurable lesions, in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (3)Patients with documented disease progression following standard systemic anti-tumor therapies (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy), those who are intolerant to such therapies, those who are medically unfit for continued treatment, or those without access to proven effective targeted agents; (4)Aged 18 to 75 years; with an Eastern Cooperative Oncology Group (ECOG) performance status score of 2–3; (5)Adequate major organ function within 7 days prior to treatment initiation, as defined by the following laboratory parameters: Hematological parameters (with no blood transfusion within 14 days): a) Hemoglobin (Hb) = 90 g/L; b) Absolute neutrophil count (ANC) = 1.5×10 9/L; c) Platelet count (PLT) = 75×10 9/L; Biochemical parameters: a) Total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN; for patients with liver metastases, ALT and AST = 5 × ULN; c) Serum creatinine (Cr) 30 ml/min/1.73 m²; Cardiac function assessment via Doppler ultrasound: Left ventricular ejection fraction (LVEF) = lower limit of normal (LLN, 30%); (6)Female subjects of childbearing potential must have a negative pregnancy test result (serum or urine human chorionic gonadotropin [HCG]) within 7 days prior to enrollment, must not be breastfeeding, and must commit to using effective contraceptive methods (e.g., intrauterine device, oral contraceptives, or condoms) during the entire trial period and for 6 months after trial completion; male subjects must also agree to use effective contraceptive measures over the same timeframe.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions must be excluded from the study: 1.Patients with known or suspected hypersensitivity to any identified component of the investigational product; 2.Patients who have received traditional Chinese medicine (TCM) treatment within 2 weeks; 3.Patients who are receiving, have planned to receive blood transfusion support (red blood cells, white blood cells, platelets) or human albumin infusion within =14 days prior to the first dose, or are expected to require continuous such infusions during the study period; patients with small cell lung cancer (including mixed small cell and non-small cell lung cancer); 4.Patients with central squamous cell lung cancer complicated by cavitation, or non-small cell lung cancer complicated by hemoptysis (>50 ml/day); 5.Patients with a history of other malignant tumors within 5 years (or current diagnosis of other malignant tumors), except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invading the basement membrane]); 6.Patients who have undergone, or plan to undergo, systemic anti-tumor therapy (including cytotoxic therapy, signal transduction inhibitors, immunotherapy) within 4 weeks prior to the start of the study or during the study period (or within 6 weeks prior to the administration of the investigational product); patients who have received elective radiotherapy (EF-RT) within 4 weeks prior to randomization, or limited-field radiotherapy for tumor lesion assessment completed within 2 weeks prior to randomization; 7.Patients with any condition that impairs oral medication administration (e.g., severe vomiting caused by intestinal obstruction, biliary obstruction, etc., resulting in inability to take medication); 8.Patients with pleural effusion or ascites (CTCAE Grade =3) accompanied by respiratory impairment; 9.Patients with brain metastases presenting with severe headache, vomiting, or other symptoms requiring emergency management; 10.Patients with any severe and/or uncontrolled diseases, including: a) Poorly controlled blood pressure (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); b) Myocardial ischemia, myocardial infarction, cardiac arrhythmias (including QTc interval =480 ms), and congestive heart failure of Grade =2 (NYHA classification); c) Active or uncontrolled severe infections (=CTCAE Grade 2 infection); d) Obstructive jaundice, liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy; e) Renal failure requiring dialysis, and unstable or rapidly progressive renal disease; f) History of immunodeficiency, including HIV positivity or other acquired/congenital immunodeficiency diseases, or history of organ transplantation; g) Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L); h) Routine urinalysis showing proteinuria =++ with confirmed 24-hour urinary protein excretion >1.0 g; i) Patients with a history of seizures requiring medical treatment; 11.Patients who have undergone major surgery (including biopsy) or suffered major trauma within 28 days prior to randomization; 12.Imaging findings indicating tumor invasion of major blood vessels, or researchers' judgment that the tumor may invade major blood vessels and cause fatal hemorrhage during the follow-up period; 13.Patients with a history of bleeding events (=CTCAE Grade 3) or at high
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life Scale Scores Related to Lung Cancer (International Scales: EORTC QLQ-C30, EORTC QLQ-LC13, FACT-L);ECOG Score;Improvement of lung cancer-related symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR); | — |
Countries
china
Contacts
Public Contactliudan
West China Hospital, Sichuan University
Outcome results
None listed