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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

NCT ID: NCT01688700

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-09-30

Brief Summary

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A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). 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

Detailed Description

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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.

Conditions

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Esophageal Squamous Cell Carcinoma Resectable

Keywords

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Esophageal Squamous Cell Carcinoma neoadjuvant therapy Nimotuzumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimotuzumab plus chemotherapy

Group Type EXPERIMENTAL

Nimotuzumab combined with paclitaxel and cisplatin

Intervention Type DRUG

Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).

Cisplatin: 75mg/m2,IV on days 1，22

paclitaxel: 90mg/m2, IV on days 1,8,22,29.

patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.

Interventions

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Nimotuzumab combined with paclitaxel and cisplatin

Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).

Cisplatin: 75mg/m2,IV on days 1，22

paclitaxel: 90mg/m2, IV on days 1,8,22,29.

patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Fan, Doctor

Role: CONTACT

Phone: 0086-571-88122192

Email: [email protected]

Facility Contacts

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Yun Fan, doctor

Role: primary

Other Identifiers

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NimoESCC

Identifier Type: -

Identifier Source: org_study_id