Clinical trial NCT05248022: Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure
Official title: Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small-Cell Lung cancer
Drug-eluting Beads Bronchial Arterial Chemoembolization
PD-1 inhibitor
advanced
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial Cancer Hospital
name: Jiangxi Chest Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Zhejiang University
First posted: 2022-02-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.
Secondary outcomes:
measure: Overall Survival
timeFrame: 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.
measure: Time to tumor untreatable progression
timeFrame: The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.
measure: Objective Response Rate
timeFrame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.
measure: Disease Control Rate
timeFrame: Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.
measure: Duration of Overall Response
timeFrame: 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.
measure: Tumor biomarkers
timeFrame: From pre-procedure to every follow-up time, assessed up to 2 years.
measure: Eastern Cooperative Oncology Group Score
timeFrame: From pre-procedure to every follow-up time, assessed up to 2 years.
measure: Recurrence rate of hemoptysis
timeFrame: From date of randomization to every follow-up time, assessed up to 2 years.
measure: Quality of life Questionare-Core score
timeFrame: From date of randomization to every follow-up time, assessed up to 2 years.
measure: The incidence of adverse events and serious adverse events
timeFrame: From date of randomization to every follow-up time, assessed up to 2 years.
measure: Pain assessment
timeFrame: From date of randomization to every follow-up time, assessed up to 2 years.
Other outcomes:
Locations:
Study officials:
affiliation: The Central Hospital of Lishui City
name: Xihui Ying, MD.
role: STUDY_DIRECTOR
References: