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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364046
• Other study ID #: ZJLS-KLDMIR-22006
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: The Central Hospital of Lishui City
• Contact: Jianfei Tu, DR.
• Phone: +8613646782878
• Email: jianfei1133[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.

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

Locations

Country	Name	City	State
China	Lishui central hospital	Lishui	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Central Hospital of Lishui City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Tumor biomarkers	carcinoembryonic antigen, carbohydrate antigen 125, squamous cell carcinoma, etc	From pre-procedure to every follow-up time, assessed up to 2 years.
Secondary	Tumor biomarkers	squamous cell carcinoma	From pre-procedure to every follow-up time, assessed up to 2 years.
Secondary	Tumor biomarkers	carbohydrate antigen 125	From pre-procedure to every follow-up time, assessed up to 2 years.
Secondary	Tumor biomarkers	carcinoembryonic antigen	From pre-procedure to every follow-up time, assessed up to 2 years.
Secondary	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..
Secondary	Recurrence rate of hemoptysis	Hemoptysis occurs again	From date of randomization to every follow-up time, assessed up to 2 years.
Secondary	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.
Secondary	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.
Secondary	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.