A phase I dose escalation study of Nimotuzumab in combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus Zhao Kuai-le 1, Hu Xi-chun 2, Wu Xiang-hua 2, Fu Xiao-long 1, Fan Min 1, Jiang Guo-liang 1 Fudan University Shanghai Cancer Center Shanghai 20032, China (presentation number 1026)

Patient eligibility (1) cytologically or histologically confirmed esophageal carcinoma; (2) age of 18–75; (3) locally advanced, stage II-IVa (AJCC, 2002); (4) performance status of ECOG 0–2; (5) no treatments prior to enrollment; (6) at least one measurable lesion on CT, MRI or esophageal barium exam; (6) normal functions of heart, lung, liver, kidney and bone marrow; (7) blood exams qualified for chemotherapy, which included hemoglobulin of ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL; and (8) informed consent signed Study design DDP: 25 mg/m2/d, d1-3, 5-FU: 1,800 mg/m2, continuous infusion in 72 h, every 4 weeks for 4 cycles; Irradiation: total dose of 61.2 Gy/34 fractions, 6.8 weeks; h-R3: weekly administration for 6 weeks, the dose escalation started with 100 mg, and followed by 200 mg and 400 mg. 3 patients will enrolled for each dose cohort.

Results: Jul, Jun, 2010, 11 patients enrolled,h-R3 100mg/W=3 cases, 200mg/W=4 cases, 400mg/W=4 cases, 2 patients withdrawed （ 200mg&400mg 1 cases, respectively ） Median follow up 10.4 months （ months ）. CR 22%, PR 56%, SD22%; 1 year OS 67%, LPFS 100% for 9 patients.

1. h-R3 of 400 mg weekly with concurrent radiotherapy and PF regimen chemotherapy was safe and well- tolerated. Maximum tolerate dose (MTD) of h-R3 has not reached yet in this study. 2. The preliminary results of outcome were encouraging. Summary