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Objective:The aim of the study was to evaluate the efficacy and toxiciiy of high power focused-beam microwave hyperthermia with intrapleural injection of Shapeilin for patients with malignant hydrothorax. Methods: Fifty-eight patients with malignant hydrothorax were divided into group A and group B randomly. All patients underwent indwelling pleural catheter and were treated by intrapleural injection of Shapeilin once three days. Treatment was composed of 3 times injection. Patients of group B received high power focused-beam microwave hyperthermia after injection of Shapeilin. Results: The response rate of group B (79.3%) was higher than that of group A (48.3%) (P < 0.05). Incidence of main adverse reactions, associated with Shapeilin, of two groups including fever and thoracodynia were similar (P > 0.05). Patients of group B didn't encounter severe toxicities of microwave hyperthermia. Conclusion: High power focused-beam microwave hyperthermia combined with intrapleural injection of Shapeilin is effective and tolerable for patients with malignant hydrothorax.