Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05248022
• Other study ID #: ZJLS-KLDMIR-21002
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 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 study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: December 31, 2024
• 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, no gender limit.

• According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.

• Tumor Node Metastasis (TNM) staging is II-III.

• According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.

• Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score = 2.

• Estimated survival time is more than 3 months.

• The patient has signed informed consent.

Exclusion Criteria:

• The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.

• The patient is accompanied by other malignant tumors and had not been cured.

• White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio = 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.

• Liver and kidney dysfunction (creatinine > 176.8 µmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).

• Uncorrectable coagulopathy or active hemoptysis.

• Patient with active infections requires antibiotic treatment.

• Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.

• Allergy to contrast agents.

• Women with pregnancy or lactation.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

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 can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. 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 vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. 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:
• Programmed Cell Death Protein 1 Inhibitor
Programmed cell death protein 1 inhibitor fixation was treated with sintilimab (Xinda Biopharmaceutical 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
The Central Hospital of Lishui City	Jiangxi Chest Hospital, Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Zhengzhou University, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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, 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	Eastern Cooperative Oncology Group Score	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.	From pre-procedure to every follow-up time, 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	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.