Phase III Study of PTX-9908 Injection to Treat Non-Removable Liver Cancer After TACE Procedure

What this Trial Is About

Researchers are evaluating PTX-9908 Injection in a Phase III clinical study involving patients with non-resectable hepatocellular carcinoma HCC who have undergone transarterial chemoembolization TACE treatment. The study aims to assess the safety, tolerability, and antitumor activity of PTX-9908 Injection in this patient population. The trial includes an open-label dose escalation phase followed by a randomized placebo-controlled dose expansion phase to better understand the treatments effects. In Phase I, the study uses an open-label design with escalating doses of PTX-9908 Injection given intravenously at several dose levels. Patients receive one dose per day for five days in the first week excluding weekends and holidays, then one dose weekly for three more weeks, completing a four-week treatment period followed by two weeks of follow-up. Phase II randomizes approximately 24 patients to receive either PTX-9908 Injection or a placebo in a 21 ratio, with dosing schedules extending to 12 weeks and a two-week follow-up period. Participants will undergo regular assessments including monitoring of adverse events, dose limiting toxicities, tumor response, and blood tests at scheduled timepoints throughout treatment and follow-up periods. Safety is evaluated weekly in Phase I and through week 16 in Phase II. Additional measures include pharmacokinetics, tumor response evaluations, and biomarkers such as AFP levels. The total study duration varies per phase but includes intensive monitoring to assess treatment effects and patient safety.

A Study of PTX-9908 Injection for Non-resectable HCC with TACE