Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

University of Chinese Academy Sciences

Status and phase

Unknown

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma Resectable

Treatments

Drug: Nimotuzumab combined with paclitaxel and cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01688700

NimoESCC

Details and patient eligibility

About

A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity

Full description

A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases. A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological or cytologic diagnosis of Esophageal squamous cell carcinoma
ECOG performance status 0-2
Age:18-70 years
Joined the study voluntarily and signed informed consent form
Patients must not have received any prior anticancer therapy
Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009）
Target lesions can be measured according to RECIST criteria
No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
Use of an effective contraceptive for adults to prevent pregnancy
Life expectancy of more than 3 months

Exclusion criteria

Not suitable to surgery
cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
early Esophageal Carcinoma(Stage I)
complete esophageal obstruction，Esophageal perforation or hematemesis
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers