NCT07284836招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Liver progression-free survival, L-PFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Abraxane+Nedaplatin
Experimental
- Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes
- Nedaplatin：Dosage: 100 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes，Treatment Cycle: Each cycle spans 3 weeks, for a total of 6-8 cycles. The exact number of cycles may be adjusted based on the patient's tolerance and disease response.
干预措施: Abraxane (Drug)
Abraxane+Nedaplatin
Experimental
- Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes
- Nedaplatin：Dosage: 100 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes，Treatment Cycle: Each cycle spans 3 weeks, for a total of 6-8 cycles. The exact number of cycles may be adjusted based on the patient's tolerance and disease response.
干预措施: Nedaplatin (Drug)
结局指标
主要结局
Liver progression-free survival, L-PFS
时间窗: Up to approximately 33 months
The period from the first liver artery chemotherapy infusion to the time of the first recorded liver tumor progression or the patient's death
次要结局
- Liver objective response rate, L-ORR(Up to approximately 33 months)
- progression-free survival, PFS(Up to approximately 33 months)
- overall survival, OS(The time from date of enrollment to the date of death due to any cause up to approximately 33 months)
研究者
研究点 (1)
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