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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-free survival
Lasso di tempo: 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
|
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.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival
Lasso di tempo: 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
|
From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.
|
|
Objective response rate
Lasso di tempo: 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
|
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
|
Disease control rate
Lasso di tempo: 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
|
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- UHCT250797
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .