drugset / Trial / NCT07284836
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
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-02-01
- Primary completion
- 2028-01-31
- Completion
- 2028-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nedaplatin | Small molecule | 100 mg | Other |
| Subject | Paclitaxel | Small molecule | 200 mg | Other |