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

NCT07284836

Phase 2 Recruiting 30 enrolled Zhejiang Cancer Hospital
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

EvaluationDrugModalityDoseRoute
Subject Nedaplatin Small molecule 100 mg Other
Subject Paclitaxel Small molecule 200 mg Other