Phase I Study of Paclitaxel Cationic Liposomes Delivered by Arterial Infusion for Advanced Solid Tumors

What this Trial Is About

Researchers are studying patients with advanced solid tumors to evaluate a new treatment called paclitaxel cationic liposomes. This Phase I clinical trial aims to assess the safety, tolerability, how the drug moves through the body, and early signs of effectiveness when given by arterial infusion. The study focuses on patients with various advanced cancers suitable for this type of chemotherapy. Participants will receive paclitaxel cationic liposomes through a catheter directly into the artery supplying the tumor. Treatment is given on the first day of each 3-week cycle, with each participant receiving between 4 to 6 cycles. Treatment may stop earlier if the disease worsens, side effects become intolerable, or other specified reasons occur. During the study, participants undergo regular monitoring for side effects, laboratory tests, and assessments of tumor response. Researchers will measure dose-limiting toxicities after the first cycle and track adverse events for up to about 3 years. Additional tests will evaluate how the drug is processed in the body and the overall impact on tumor control and survival. Participants are followed closely throughout and after treatment as part of the study.

A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors