The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study

Обзор

The goal of this clinical trial is to learn about Drug loaded microspheres for bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced NSCLC after second-line treatment. The main question it aims to answer is: The efficacy and safety of Drug Loading Beads Bronchial Arterial Chemoembolization (DEB-BACE) combined with Anlotinib and Adebelimumab in the third line treatment of advanced NSCLC. Participants will receive DEB-BACE treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of Anlotinib and Adebelimumab. With a maximum of 4 DEB-BACE treatments depending on the therapeutic effect, followed by continued treatment with Anlotinib and Adebelimumab.

Вмешательства

• Препарат Anlotinib
  After receiving DEB-BACE treatment, the enrolled patients will rest for one week and then undergo one cycle of treatment with the combination of Anlotinib and Adebelimumab. After one course of treatment, the efficacy will be re evaluated, such as CR, and the treatment with Anlotinib and Adebelimumab will continue; For PR, SD, or PD, continue to receive DEB-BACE combined with anlotinib and adebelimumab as needed, with a maximum of 4 DEB-BACE treatments, followed by continued treatment with anloti

Первичные конечные точки

• ORR [Срок оценки: 1 year]

Вторичные конечные точки (5)

• PFS [Срок оценки: 2 years]
• OS [Срок оценки: 3 years]
• DCR [Срок оценки: 3 years]
• DoR [Срок оценки: 3 years]
• AE [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Age>18 years old, gender unlimited;
• According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;
• TNM staging is III - IV;
• Failure of second-line treatment according to the CSCO guidelines;
• ECOG PS score ≤ 2 points;
• Estimated survival time>3 months;
• Sign informed consent form

Критерии исключения

• Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;
• Patients with other malignant tumors that have not been cured;
• White blood cells<3 × 109/L, absolute value of neutrophils<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count<50 × 109/L, hemoglobin concentration<90 g/L;
• Liver and kidney dysfunction (creatinine>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>twice the normal upper limit;
• Central squamous cell carcinoma with cavity features;
• Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
• Patients with concurrent active infections who require antibiotic treatment;
• Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
• Contrast agent allergy;
• Women with concurrent pregnancy or lactation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Kaitai Liu — Ningbo

Идентификаторы

NCT: NCT06188650 · KY2023PJ261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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