Lung Squamous Cell Carcinoma Stage IV
Conditions
Keywords
quamous cell carcinoma of the lung, interventional bronchial artery chemoembolization
Brief summary
This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous cell carcinoma.
Detailed description
This study aimed to evaluate the differences in efficacy (e.g., progression-free survival, overall survival, objective response rate, and incidence of adverse events) and safety (e.g., incidence of adverse events) between tislelizumab therapy combined with 1-3 cycles of bronchial artery chemoembolization (with gemcitabine) and tislelizumab monotherapy in patients with stage IV squamous cell lung cancer who achieved partial remission or disease stabilization after standard first-line treatment (carboplatin + paclitaxel chemotherapy + tislelizumab immunotherapy, 4-6 cycles). The goal was to explore ways to optimize first-line treatment strategies and further improve the overall efficacy of first-line treatment for patients with advanced squamous cell lung cancer.
Interventions
PROCEDUREImmunotherapy combined with interventional therapy group
Tislelizumab 200mg, intravenous infusion, every 3 weeks, for 2 years. Simultaneously, the patient undergoes 1-3 sessions of transbronchial chemoembolization (BACE). A follow-up enhanced CT scan of the lungs and mediastinum is performed 4-6 weeks after BACE. Based on the results, the investigator will assess whether further BACE is necessary, with a maximum of 3 BACE sessions per patient.
DRUGImmunotherapy group
Tislelizumab 200 mg, IV infusion, Q3W, maintenance for 2 years. Follow up with enhanced CT scans of the lungs and mediastinum every 4-6 weeks, and assess efficacy according to RECIST 1.1 criteria.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Squamous cell carcinoma of the lung confirmed by histology or cytology; 2. According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV. 3. Has received standard first-line chemotherapy immunotherapy for 4\~6 cycles, and achieved partial remission or disease stability according to the efficacy evaluation of RECIST1.1; 4. The patient is 18-80 years old; 5. ECOG PS score is 0-1; 6. The main organ functions meet the following criteria: (1) Blood routine examination: hemoglobin (HB) ≥ 90g/L; Leukocyte (ANC) ≥ 3.0× 109/L; Neutrophils ≥ 1.5× 109/L; Platelet (PLT) ≥ 75× 109/L; (2) Biochemical examination: albumin (ALB)≥29g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2uln; Total bilirubin (TBIL) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN; 7. Patients and/or their families agree to participate in clinical trials and sign informed consent forms; 8. No history of other malignant tumors; 9. No active infection; 10. Be able to cooperate with research follow-up; 11. At least one measurable lesion (according to RECIST 1.1); 12. The expected survival time is more than 3 months.
Exclusion criteria
1. There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation; 2. Have a history of allergy to contrast agents or chemotherapy drugs; 3. Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy; 4. Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women); 5. Coagulation function is seriously abnormal and cannot be corrected; 6. Hypertension patients still have poor blood pressure control (systolic blood pressure \> \>160mmHg, diastolic blood pressure \> 100 mmhg) after antihypertensive drugs treatment; 7. Pregnant or lactating female patients; 8. Have a history of mental illness or psychotropic drug abuse; 9. Patients with symptomatic brain metastasis; 10. Patients with autoimmune diseases;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. | From date of randomization until the date of first documented progression or date of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion. | From date of randomization until the date of death from any cause |
| Objective response rate | 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months | Proportion of patients with reduction in stable in tumor burden of a predefined amount |
| Disease control rate | 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months | Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount |
Outcome results
None listed