研究目的
To evaluate the efficacy and safety of photodynamic therapy (PDT) using talaporfin sodium as a salvage treatment for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for esophageal cancer (EC).
研究成果
The efficacy and safety of second-generation PDT using talaporfin sodium for local failure of EC after CRT will be reported. The study aims to provide a less toxic and more convenient treatment option for patients with local failure after CRT or RT for EC.
研究不足
The study is limited by its phase IIB design, which may not fully capture the long-term efficacy and safety profile of the treatment. Additionally, the sample size of 26 patients may not be sufficient to detect rare adverse events.
1：Experimental Design and Method Selection:
A multicenter phase IIB study was conducted to evaluate the efficacy and safety of PDT using talaporfin sodium.
2：Sample Selection and Data Sources:
Eligibility criteria included histologically proven local failure of ≤3 cm in diameter with a clinical depth limited within T2 after definitive CRT or RT (≥50 Gy) for EC.
3：List of Experimental Equipment and Materials:
Talaporfin sodium (Laserphyrin?) and a diode laser were used.
4：Experimental Procedures and Operational Workflow:
PDT commenced with intravenous administration of 40 mg/m2 of talaporfin sodium, followed by diode laser irradiation with a fluence of 100 J/cm2 and a fluence rate of 150 mW/cm2 4-6 h later.
5：Data Analysis Methods:
The primary endpoint was the local complete response (L-CR) rate, and the secondary endpoints were confirmed L-CR, local progression-free survival, progression-free survival, local time to treatment failure, and overall survival.
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