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

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 Overview

• Status: Not yet recruiting
• Conditions: Carcinoma; Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Serplulimab; Procedure: Intravenous chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianfei Tu, DR.; Phone Number: +8613646782878; Email: jianfei1133@163.com

Study Locations

• China
  • Zhejiang
    • Lishui, Zhejiang, China, 323000
      • Lishui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab	Procedure: Drug-eluting beads bronchial arterial chemoembolization; 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.; Drug: Serplulimab; 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.
Active Comparator: Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab	Drug: Serplulimab; 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.; Procedure: Intravenous chemotherapy; Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Evaluation index of clinical efficacy of anticancer drugs.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The best efficacy endpoint in cancer clinical trials.	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.	The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.
Tumor biomarkers	carcinoembryonic antigen, carbohydrate antigen 125, squamous cell carcinoma, etc	From pre-procedure to every follow-up time, assessed up to 2 years.
Recurrence rate of hemoptysis	Hemoptysis occurs again	From date of randomization to every follow-up time, assessed up to 2 years.
Quality of life Questionare-Core score	The European Organization for Reasearch and Treatment of Cancer Quality of life Questionare-Core score. All items and subscales were converted from 0 to 100, with higher scores indicating better overall quality of life.	From date of randomization to every follow-up time, assessed up to 2 years.
Progression Free Survival	The most common primary endpoint in cancer trials.	The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years
Disease Control Rate	Evaluation index of clinical efficacy of anticancer drugs	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.	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
Tumor biomarkers	squamous cell carcinoma	From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers	carbohydrate antigen 125	From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers	carcinoembryonic antigen	From pre-procedure to every follow-up time, assessed up to 2 years.
Eastern Cooperative Oncology Group Score	Time Frame: From pre-procedure to every follow-up time, assessed up to 2 years.	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..
The incidence of adverse events and serious adverse events	Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Time Frame: From date of randomization to every follow-up time, assessed up to 2 years.
Pain assessment	Visual Analogue Scale/Score.The tool is a 10 cm long roving ruler with 11 scales ranging from 0 to 10. A score of 0 means no pain, and a score of 10 means unbearable pain. The higher the score, the more severe the pain	From date of randomization to every follow-up time, assessed up to 2 years.

Collaborators and Investigators

• Sponsor: The Central Hospital of Lishui City
• Investigators: Study Director: Linqiang Lai, MD., The Central Hospital of Lishui City

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer; Serplulimab; Programmed Cell Death Protein 1 Inhibitor; Drug-eluting beads bronchial arterial chemoembolization
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZJLS-KLDMIR-22006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
• IPD Sharing Time Frame: Within six months after the trial is completed.

IPD Sharing Access Criteria

Shared data is not available for downloading, but can only be browsed. To download the data, you must contact the researchers.

Shared data does not provide any private information of the participants.

• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No