Evaluating Paclitaxel Polymeric Micelles for Injection in Adults with Taxane-Resistant Advanced Pancreatic, Cholangiocarcinoma, Lung, Stomach, Esophageal, or Breast Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of Paclitaxel Polymeric Micelles for Injection in patients with advanced cancers that include pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer, all resistant to previous Taxane treatments. This phase II trial aims to assess the objective remission rate among these patients who have limited response to standard therapies. Participants receive intravenous Paclitaxel Polymeric Micelles at a dose of 300 mgm2 administered over at least 3 hours every three weeks, which constitutes one treatment cycle. Treatment continues without interruption until disease progression, intolerable side effects, the start of a new cancer therapy, withdrawal, death, or loss to follow-up. This single-arm trial involves a small sample size to evaluate the treatment effect. During the study, patients undergo regular assessments to monitor disease status and safety, including tracking objective response rate, progression-free survival, disease control rate, overall survival, and adverse events for up to 24 months. Participants are closely followed for treatment tolerance and disease changes, with the goal of understanding the treatment impact and potential risks over this period.

Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer