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
NCT ID: NCT07284836
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-02-01
2028-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abraxane+Nedaplatin
1. Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes
2. 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.
Abraxane
Abraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks
Nedaplatin
Nedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks
Interventions
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Abraxane
Abraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks
Nedaplatin
Nedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Hu Hai
MD
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2024-467
Identifier Type: -
Identifier Source: org_study_id