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The primary end points were the completion of full treatment and endoscopic complete response rate (ECRR).
The complete response rate was 17.5%.
The pathological complete response rate was 5.3% of operated patients and 4.3% of total patients.
The pathologic complete response rate was 16% (42% in the mediastinal lymph nodes).
Confirmed objective response rate was 62%, with a complete response rate of 33% per immune-related response criteria.
The complete response rate in the historical control group was 70% (40/57), showing no difference in efficacy.
Of 10 patients assessable for response, 7 (70%) responded at 12 weeks, with a 30% complete response rate.
Chemotherapy alone achieved a 75%% complete response rate.
Response and toxicity were scored using conventional criteria.The complete response rate for the total study population was 41%.
Patients undergoing biopsy of the primary tumor site after the therapies had 17/18 (94%) pathologic complete response rate.
The complete response rate was not significantly affected by the number of hyperthermia treatments given per week.
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