Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Programmed Cell Death Protein 1 Inhibitor

• Registration Number: NCT05248022
• Lead Sponsor: The Central Hospital of Lishui City

Brief Summary

This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Study Start: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Age more than 18 years old, no gender limit.
• According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
• Tumor Node Metastasis (TNM) staging is II-III.
• According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
• Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
• Estimated survival time is more than 3 months.
• The patient has signed informed consent.

Exclusion Criteria

• The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
• The patient is accompanied by other malignant tumors and had not been cured.
• White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
• Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
• Uncorrectable coagulopathy or active hemoptysis.
• Patient with active infections requires antibiotic treatment.
• Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
• Allergy to contrast agents.
• Women with pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Treatment Group	Programmed Cell Death Protein 1 Inhibitor	Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.
Single Treatment Group	Drug-eluting beads bronchial arterial chemoembolization	Only receive drug-eluting beads bronchial arterial chemoembolization treatment.
Combination Treatment Group	Drug-eluting beads bronchial arterial chemoembolization	Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.	The most common primary endpoint in cancer trials.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.	The best efficacy endpoint in cancer clinical trials.
Duration of Overall Response	The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.
Objective Response Rate	Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.
Pain assessment	From date of randomization to every follow-up time, assessed up to 2 years.	Visual Analogue Scale/Score.The tool is a 10 cm long roving ruler with 11 scales ranging from 0 to 10. A score of 0 means no pain, and a score of 10 means unbearable pain. The higher the score, the more severe the pain.
Disease Control Rate	Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.	Evaluation index of clinical efficacy of anticancer drugs.
Eastern Cooperative Oncology Group Score	From pre-procedure to every follow-up time, assessed up to 2 years.	The patient's performance status score is divided into 6 grades. The lowest grade is 0, and the highest grade is 5. The patient's physical state deteriorates as the grade rises.
Quality of life Questionare-Core score	From date of randomization to every follow-up time, assessed up to 2 years.	The European Organization for Reasearch and Treatment of Cancer Quality of life Questionare-Core score. All items and subscales were converted from 0 to 100, with higher scores indicating better overall quality of life.
The incidence of adverse events and serious adverse events	From date of randomization to every follow-up time, assessed up to 2 years.	Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time to tumor untreatable progression	The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.	End point of antitumor drug trial.
Tumor biomarkers	From pre-procedure to every follow-up time, assessed up to 2 years.	carcinoembryonic antigen, carbohydrate antigen 125, squamous cell carcinoma, etc
Recurrence rate of hemoptysis	From date of randomization to every follow-up time, assessed up to 2 years.	Hemoptysis occurs again