Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

The Central Hospital of Lishui City56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma Small Cell Lung Cancer

Interventions

Drug-eluting beads bronchial arterial chemoembolizationPROCEDURE

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.

SerplulimabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lishui central hospital

Lishui, Zhejiang, China

Outcomes

Primary Outcomes

Objective response rate

Evaluation index of clinical efficacy of anticancer drugs.

Time frame: 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

Progression Free Survival

The most common primary endpoint in cancer trials.

Time frame: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years

Overall Survival

The best efficacy endpoint in cancer clinical trials.

Time frame: 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.

Time to tumor untreatable progression

End point of antitumor drug trial.

Time frame: The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.

Disease Control Rate

Evaluation index of clinical efficacy of anticancer drugs

Time frame: Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.

Duration of Overall Response

Evaluation index of clinical efficacy of anticancer drugs.

Time frame: 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

Central Contacts

Jianfei Tu, DR.

CONTACT

+8613646782878 jianfei1133@163.com

Data from ClinicalTrials.gov

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