Clinical trial NCT06364046: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
Official title: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC:A Prospective, Single-center, Randomized, Open, Double-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma
Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Programmed Cell Death Protein 1 Inhibitor
Serplulimab
Drug-eluting beads bronchial arterial chemoembolization
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 56
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 project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years old, regardless of gender;
* SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
* TNM stage II-IV;
* ECOG PS score ≤2;
* Predicted survival time more than 3 months;
* Provision of signed informed consent.

Exclusion Criteria:

* Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
* Concurrent presence of other incurable malignant tumors;
* White blood cell count less than 3×10\^9/L, neutrophil absolute count less than 1.5×10\^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10\^9/L, hemoglobin concentration less than 90 g/L;
* Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
* Uncorrectable coagulopathy or concurrent active hemoptysis;
* Complicated with active infection requiring antibiotic treatment;
* Uncontrolled hypertension, diabetes, or cardiovascular disease;
* Allergy to contrast agents;
* Women who are pregnant or lactating.

Primary outcomes:
measure: Objective response rate
timeFrame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed up to 12 months
Secondary 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
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: 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: Tumor biomarkers
timeFrame: From pre-procedure to every follow-up time, assessed up to 2 years.
measure: Tumor biomarkers
timeFrame: From pre-procedure to every follow-up time, assessed up to 2 years.
measure: Tumor biomarkers
timeFrame: From pre-procedure to every follow-up time, assessed up to 2 years.
measure: Eastern Cooperative Oncology Group Score
timeFrame: 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,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: Time Frame: 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:
city: Lishui
country: China
facility: Lishui central hospital
state: Zhejiang
Study officials:
affiliation: The Central Hospital of Lishui City
name: Linqiang Lai, MD.
role: STUDY_DIRECTOR
References: