Clinical trial · Interventional

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

NCT07567313CI-TRIAL-00110416not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Squamous Cell Carcinoma Stage IV	Lung Squamous Cell Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Immunotherapy combined with interventional therapy group	Procedure	—	UNRESOLVED
Immunotherapy group	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Immunotherapy group
interventionNames
1. Drug: Immunotherapy group
type
EXPERIMENTAL
label
Immunotherapy combined with interventional therapy group
interventionNames
1. Procedure: Immunotherapy combined with interventional therapy group

Primary outcomes (1)

measure
Progression-free survival
timeFrame
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.
description
From date of randomization until the date of first documented progression or date of death from any cause

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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;

References

Publications (1)

BACKGROUND1. 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.