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

NCT06364046 | Not Yet Recruiting

• 1 other identifier: ZJLS-KLDMIR-22006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Programmed Cell Death Protein 1 Inhibitor; Serplulimab; Drug-eluting beads bronchial arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Progression Free Survival

  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

  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

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

• Disease Control Rate

  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

  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

Study Arms (2)

Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab

EXPERIMENTAL

Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Serplulimab

Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab

ACTIVE COMPARATOR

Drug: Serplulimab; Procedure: Intravenous chemotherapy

Interventions

Drug-eluting beads bronchial arterial chemoembolization PROCEDURE

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-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab

Serplulimab DRUG

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.

Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab; Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab

Intravenous chemotherapy PROCEDURE

Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days

Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Central Hospital of Lishui City: lead

Study Sites (1)

Lishui central hospital

Lishui, Zhejiang, 323000, China

Location

MeSH Terms

Conditions

Carcinoma; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Linqiang Lai, MD.

  The Central Hospital of Lishui City

  STUDY DIRECTOR

Central Study Contacts

Jianfei Tu, DR.

CONTACT

+8613646782878; jianfei1133@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 15, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Within six months after the trial is completed.
• 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.

Locations

CN (1)