Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

• Status: Withdrawn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

Summary

There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.

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

Details

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

Criteria

Inclusion Criteria:

• Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.

• Males or females aged ≥18 years, < 75 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Life expectancy ≥12 weeks.

• Adequate bone marrow, renal, and liver function are required.

• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

• Allergy to anti-EGFR antibody.

• Female subjects should not be pregnant or breast-feeding.

• Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.