Stage IV Lung Squamous Cell Carcinoma Treated With or Wit... | NCT07567313

NCT07567313

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immunotherapy group	Active Comparator		Drug: Immunotherapy group
Immunotherapy combined with interventional therapy group	Experimental		Procedure: Immunotherapy combined with interventional therapy group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunotherapy combined with interventional therapy group	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	From date of randomization until the date of first documented progression or date of death from any cause	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.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	From date of randomization until the date of death from any cause	From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.
Objective response rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Squamous cell carcinoma of the lung confirmed by histology or cytology;
According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV.
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;
The patient is 18-80 years old;
ECOG PS score is 0-1;
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;
Patients and/or their families agree to participate in clinical trials and sign informed consent forms;
No history of other malignant tumors;
No active infection;
Be able to cooperate with research follow-up;
At least one measurable lesion (according to RECIST 1.1);
The expected survival time is more than 3 months.

Exclusion Criteria:

There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation;
Have a history of allergy to contrast agents or chemotherapy drugs;
Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy;
Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women);
Coagulation function is seriously abnormal and cannot be corrected;
Hypertension patients still have poor blood pressure control (systolic blood pressure > >160mmHg, diastolic blood pressure > 100 mmhg) after antihypertensive drugs treatment;
Pregnant or lactating female patients;
Have a history of mental illness or psychotropic drug abuse;
Patients with symptomatic brain metastasis;
Patients with autoimmune diseases;

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024, 74(3): 229-263. 2. Lortet-Tieulent J, Soerjomataram I, Ferlay J, Rutherford M, Weiderpass E, Bray F. International trends in lung cancer incidence by histological subtype: adenocarcinoma stabilizing in men but still increasing in women. Lung Cancer 2014, 84(1): 13-22. 3. Cheng TY, Cramb SM, Baade PD, Youlden DR, Nwogu C, Reid ME. The International Epidemiology of Lung Cancer: Latest Trends, Disparities, and Tumor Characteristics. J Thorac Oncol 2016, 11(10): 1653-1671. 4. Socinski MA, Obasaju C, Gandara D, Hirsch FR, Bonomi P, Bunn PA, Jr., et al. Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. J Thorac Oncol 2018, 13(2): 165-183. 5. He G, Yang K, Zhang X, Pan J, Han A, Gao Z, et al. Bronchial artery chemoembolization with drug-eluting beads versus bronchial artery infusion followed by polyvinyl alcohol particles embolization for advanced squamous cell lung cancer: A retrospective study. Eur J Radiol 2023, 161: 110747. 6. Network NCC. Non-small cell lung cancer (version 4.2025). 2025. 7. Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, et al. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol 2018, 13(11): 1743-1749. 8. Novello S, Kowalski DM, Luft A, Gumus M, Vicente D, Mazieres J, et al. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol 2023, 41(11): 1999-2006.