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

NCT07567313 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: UHCT250797
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Squamous Cell Carcinoma Stage IV

Keywords

quamous cell carcinoma of the lung; interventional bronchial artery chemoembolization

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Overall Survival

  From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.

• Objective response rate

  2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

• Disease control rate

  2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

Study Arms (2)

Immunotherapy group

ACTIVE COMPARATOR

Drug: Immunotherapy group

Immunotherapy combined with interventional therapy group

EXPERIMENTAL

Procedure: Immunotherapy combined with interventional therapy group

Interventions

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.

Immunotherapy combined with interventional therapy group

Immunotherapy group DRUG

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.

Immunotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 5, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-01