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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07284836•Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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.
+7 more criteria

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.
+6 more criteria

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 1, 2025

Primary Completion Date

January 31, 2028

Completion Date

January 31, 2028

Last Updated

December 16, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatic Artery InfusionLiver Metastasis of Breast Cancer

Interventions

Abraxane

DRUG

Nedaplatin

DRUG

Contacts

Xaolin Li

CONTACT

8615024437258 847678911@qq.com