Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard Therapy

Обзор

Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment. Outcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS) Participants will: * Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle. * Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.

Вмешательства

• Препарат Abraxane
  Abraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks
• Препарат Nedaplatin
  Nedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks

Первичные конечные точки

• Liver progression-free survival, L-PFS [Срок оценки: Up to approximately 33 months]

Вторичные конечные точки (3)

• Liver objective response rate, L-ORR [Срок оценки: Up to approximately 33 months]
• progression-free survival, PFS [Срок оценки: Up to approximately 33 months]
• overall survival, OS [Срок оценки: The time from date of enrollment to the date of death due to any cause up to approximately 33 months]

Критерии участия

Критерии включения

• Patients with liver metastases from breast cancer pathologically confirmed via surgery or biopsy.

• Advanced breast cancer patients with imaging-confirmed visceral tumor burden solely confined to liver metastases.

• Patients who have previously failed at least two lines of standard therapy (including endocrine therapy, chemotherapy, or targeted therapy), or those for whom researchers determine that local therapy would yield greater benefit.

• Age 18-70 years.

• ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2. • 0: Fully active, without any restrictions; • 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work; • 2: Ambulatory and capable of all self-care but unable to carry out any work activities.

• Liver function score (e.g., Child-Pugh) Class A-B.

• Class A (5-6 points): Good hepatic reserve, well tolerated to surgery, low incidence of postoperative complications and mortality;

• Class B (7-9 points): Moderately impaired hepatic reserve, poorly tolerated to surgery, increased postoperative complications and mortality;

• Class C (≥10 points): Severely impaired hepatic reserve, very poorly tolerated to surgery, high risk of postoperative complications and mortality; surgery is generally not recommended.

⑦ Adequate organ function.

• Hemoglobin ≥90 g/L, white blood cells ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L;

• Serum creatinine ≤1.0×upper normal limit (UNL), and creatinine clearance >60 mL/min;

• Alanine aminotransferase (ALT) ≤1.5×UNL, aspartate aminotransferase (AST) ≤1.5×UNL, alkaline phosphatase (ALP) ≤1.5×UNL;

• Total bilirubin (TBIL) ≤1.5×UNL;

• No severe abnormalities on electrocardiogram, left ventricular ejection fraction (LVEF) ≥50%;

• Absence of other severe medical conditions or comorbidities that would preclude tolerance to the clinical trial intervention.
• Signed informed consent, indicating understanding of the trial's purpose, risks, and potential benefits.

Критерии исключения

• History of other malignancies.
• Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.
• Tumor volume ≥70% of liver volume.
• History of heart failure (NYHA class >I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.
• Active infection, severe allergic reactions, or autoimmune diseases, including but not limited to:

• Active tuberculosis (TB), currently receiving or having received anti-TB treatment within the past year;
• HIV infection (HIV1/2 antibody positive);
• Active hepatitis B or hepatitis C virus infection;
• History of systemic lupus erythematosus, rheumatoid arthritis, chronic lymphocytic thyroiditis, hyperthyroidism, polyarteritis nodosa, autoimmune hemolytic anemia, etc.
• Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.
• Uncontrolled hypertension, diabetes, or other serious diseases.
• Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs.
• Pregnant or lactating patients.
• History of mental illness.
• Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs.
• Current participation in another clinical trial.

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

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07284836 · IIT-2024-467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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