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Trial Title:
Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
NCT ID:
NCT06364046
Condition:
Carcinoma
Small Cell Lung Cancer
Conditions: Official terms:
Small Cell Lung Carcinoma
Conditions: Keywords:
Small Cell Lung Cancer
Programmed Cell Death Protein 1 Inhibitor
Serplulimab
Drug-eluting beads bronchial arterial chemoembolization
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Drug-eluting beads bronchial arterial chemoembolization
Description:
Drug-eluting beads bronchial arterial chemoembolization generally uses
platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin)
combined treatment, and drug-loaded microspheres are loaded with irinotecan. The dose of
chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through
catheter infusion is reduced by 25%. The dose of drug-loaded drugs is irinotecan 80mg/
m2. Chemotherapy was perfused first, followed by embolization with drug-loaded
microspheres, until the blood flow in the artery supplying the tumor slowed down and
approached stagnation. The number of DEB-BACE treatments is determined by the
investigator, and is given as needed according to the patient's condition, usually 1-2
times, with an interval of 28±10 days.
Arm group label:
Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Programmed cell death protein 1 inhibitor fixation was treated with serplulimab (Fuhong
Hanlin Co., LTD.). It is administered by intravenous infusion, and the recommended dose
is 200 mg, given once every 21 days. The medication will last for two years until disease
progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive
agents will not be replaced and the dose will not be adjusted.
Arm group label:
Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
Arm group label:
Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
Intervention type:
Procedure
Intervention name:
Intravenous chemotherapy
Description:
Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21
days
Arm group label:
Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lishui central hospital
Address:
City:
Lishui
Zip:
323000
Country:
China
Start date:
April 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The Central Hospital of Lishui City
Agency class:
Other
Source:
The Central Hospital of Lishui City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364046
