Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma
- Registration Number
- NCT02034968
- Lead Sponsor
- Zhejiang University
- Brief 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.
- Detailed Description
In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nimotuzumab & nab-paclitaxel & cisplatin Nimotuzumab Nimotuzumab: 200mg,IV once a week during chemotherapy. Nab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle Cisplatin: 75mg/m2,IV on 21 day cycle
- Primary Outcome Measures
Name Time Method Progression free survival(PFS) 12 months
- Secondary Outcome Measures
Name Time Method Objective Response Rate From date of treatment until the date of progression, assessed up to 2 months
Trial Locations
- Locations (1)
The first affiliated hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China