Non-small cell lung cancer
Conditions
Interventions
Venous group :PD-1 or PD-L1 inhibitors administered via peripheral intravenous infusion
bronchial artery infusion (BAI) group:PD-1 or PD-L1 inhibitors administered via bronchial artery infusion
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old. 2. Histopathology or cytology confirmed as NSCLC, and staging with chest CT, head CT or MRI, whole-body bone scan, and abdominal ultrasound confirming stage III or IV. If stage III NSCLC, must be evaluated by an experienced surgeon as unresectable. 3. Must have at least one measurable lesion as a target lesion (according to RECIST 1.1 criteria). 4. Lack of EGFR sensitive mutations (i.e., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S7681 mutations), ALK rearrangements, and ROS1 positivity. 5. PD-L1 expression results available. 6. Bronchial artery CTA or enhanced CT confirming the presence of independently perfused target bronchial arteries in the primary lesion. 7. Standard first-line immunotherapy combined with chemotherapy for 2 or 4 cycles without achieving PR or with PD. 8. Expected survival time = 12 weeks. 9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 10. No severe heart, brain, lung, kidney, or other diseases that may affect the patient's survival. 11. Agree to participate in this clinical study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate surgery due to cardiopulmonary insufficiency. 2. Patients with abnormal liver or kidney function unable to tolerate surgery. 3. Severe conditions affecting patient survival such as heart, brain, lung, or kidney diseases. 4. Other serious conditions that may prevent bronchial artery infusion therapy, such as unstable angina, acute myocardial infarction within the past six months, congestive heart failure, etc. 5. History of other malignant tumors within the past five years. 6. Contraindications for bronchial artery infusion therapy, such as severe coagulation disorders, uncontrolled local infections at the puncture site, contrast agent allergies, etc. 7. Contraindications for PD-1/PD-L1 inhibitor therapy. 8. Patients with symptomatic brain metastases, history of spinal cord compression, or meningeal metastases. 9. Refusal to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS);Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease control rate (DCR);The safety of PD-1 and PD-L1 inhibitors bronchial artery infusion therapy.;Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactGuo Shuliang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed