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A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma


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

Thank you

Trial Information

A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathology complete remission rate

Outcome Description:

Pathology complete remission rate is the primary outcome measure.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

NimoESCC

NCT ID:

NCT01688700

Start Date:

September 2012

Completion Date:

September 2017

Related Keywords:

  • Esophageal Squamous Cell Carcinoma Resectable
  • Esophageal Squamous Cell Carcinoma
  • neoadjuvant therapy
  • Nimotuzumab
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

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