Clinical trial · Interventional
Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug-eluting beads bronchial arterial chemoembolization | Procedure | — | UNRESOLVED |
| Intravenous chemotherapy | Procedure | — | UNRESOLVED |
| Serplulimab | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
- interventionNames
- Procedure: Drug-eluting beads bronchial arterial chemoembolization
- Drug: Serplulimab
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
- interventionNames
- Drug: Serplulimab
- Procedure: Intravenous chemotherapy
Primary outcomes (1)
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available