AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 2Ages 18 Years - 70 YearsFemaleZhejiang Cancer Hospital
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: 1. History of other malignancies. 2. Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver. 3. Tumor volume ≥70% of liver volume. 4. History of heart failure (NYHA class \>I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia. 5. 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. 6. Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period. 7. Uncontrolled hypertension, diabetes, or other serious diseases. 8. Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs. 9. Pregnant or lactating patients. 10. History of mental illness. 11. Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs. 12. Current participation in another clinical trial.
💊

What it tests

  • Abraxane
  • Nedaplatin
📍

Where

1 site
Zhejiang Cancer Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy