Actively Recruiting
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
Led by Zhejiang Cancer Hospital · Updated on 2025-12-16
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Liver metastases from breast cancer confirmed by surgery or biopsy
- Advanced breast cancer patients with tumor spread only to the liver as shown by imaging
- Prior failure of at least two lines of standard therapy including endocrine, chemotherapy, or targeted treatments, or deemed likely to benefit more from local therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Liver function classified as Child-Pugh class A or B
- Adequate organ function including hemoglobin ≥90 g/L, white blood cells ≥3.5 x 10⁹/L, neutrophils ≥1.5 x 10⁹/L, platelets ≥100 x 10⁹/L
- Serum creatinine below 1.0 times upper normal limit and creatinine clearance over 60 mL/min
- Liver enzymes (ALT, AST, ALP) and total bilirubin no more than 1.5 times upper normal limit
- No severe abnormalities on electrocardiogram; left ventricular ejection fraction ≥50%
- No other severe medical conditions or comorbidities that would prevent tolerance to treatment
- Signed informed consent indicating understanding of trial purpose, risks, and benefits
You will not qualify if you...
- History of other cancers
- Breast or chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or metastases outside the liver
- Tumor volume occupying 70% or more of liver volume
- History of heart failure worse than NYHA class I, heart attack, unstable angina, stroke, or uncontrolled arrhythmia
- Active infections or severe allergic reactions including active tuberculosis, HIV infection, active hepatitis B or C, and autoimmune diseases such as lupus or rheumatoid arthritis
- Receipt of live attenuated vaccines within 4 weeks before enrollment or planned during the study
- Uncontrolled high blood pressure, diabetes, or other serious diseases
- Severe uncontrolled dysfunction of liver, kidneys, lungs, or other vital organs
- Pregnancy or breastfeeding
- History of mental illness
- Known allergy to albumin-bound paclitaxel, nedaplatin, or similar drugs
- Current participation in another clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xaolin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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