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Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients

Phase 2
18 Years
70 Years
Open (Enrolling)
Esophageal Squamous Cell Carcinoma

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Trial Information

Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients

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.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and
practically eliminates the risk of hypersensitivity reactions associated with solvent-based
paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with
nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

Inclusion Criteria:

- Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ
by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.

- Age ranges from 18 to 70 years.

- Patients must not have received any prior anticancer therapy.

- Performance status of 0 to 1

- Estimated life expectancy of at least 6 months.

- Tumor can be measured according to RECIST criteria

- Signed informed consent document on file.

- Females with childbearing potential must have a negative serum pregnancy

- Adequate organ function including the following:

Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets
greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total
bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine
transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN
Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study

Exclusion Criteria:

- Carcinoma at the upper part of esophagus

- Histologic diagnosis of adenocarcinoma of esophagus.

- Prior treatment for esophageal cancer.

- Active infection.

- Pregnant or breast feeding.

- History of significant neurological or mental disorder, including seizures or

- Prior invasive malignancy in 5 years (except for carcinoma in situ).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response to induction therapy

Outcome Description:

The response to induction therapy will be evaluated

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Weimin Mao, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Zhejiang Cancer Hospital


China: Ministry of Health

Study ID:




Start Date:

December 2010

Completion Date:

October 2015

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • esophageal squamous cell carcinoma
  • neoadjuvant chemotherapy
  • albumin-bound paclitaxel
  • cisplatin
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms