Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Nimotuzumab; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)

• Locally advanced disease that is technically operable with curative intent (R0)

• T3, N0 OR T1-3, N+ OR T4, Nx

• No T1-2, N0

• No inoperable T4 (unequivocal organ involvement)

• No distant metastasis, including M1a lymph node status

• Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology

• No carcinoma of the cervical esophagus

• Obstructive tumors allowed

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

• History of serious allergic or castor oil allergy

• Patients who are not suitable to participate in the trial according to researchers