Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study of Patients With Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Squamous Cell Carcinoma Stage IV
• Intervention / Treatment: Drug: Immunotherapy group; Procedure: Immunotherapy combined with interventional therapy group

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immunotherapy group	Drug: Immunotherapy 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.
Experimental: Immunotherapy combined with interventional therapy group	Procedure: Immunotherapy 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Proportion of patients with reduction in stable in tumor burden of a predefined amount	2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
Disease control rate	Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount	2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: quamous cell carcinoma of the lung; interventional bronchial artery chemoembolization
• Other Study ID Numbers: UHCT250797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Involving patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No