Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

Biotech Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Carcinoma

Treatments: Drug: Nimotuzumab; Drug: Placebo; Radiation: Radiotherapy; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01232374

BT-ESO-1001

Details and patient eligibility

About

Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) 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 chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Full description

The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Joined the study voluntarily and signed informed consent form;
• Age 18-75
• Both genders
• Esophageal squamous cell carcinoma confirmed by pathology
• Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
• No radiotherapy, chemotherapy or other treatments prior to enrollment
• PS ECOG 0-2
• Life expectancy of more than 3 months
• Target lesions measurable
• Hemoglobin（Hb）≥9 g/dL
• WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
• platelet count (Pt) ≥100x 109/L
• Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
• Renal function: creatinine < 1.5 x ULN
• No immuno-deficiency
• Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion criteria

• Complete esophageal obstruction
• Deep esophageal ulcer
• Esophageal perforation
• Haematemesis
• After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
• Esophageal stent or tracheal stent placed
• Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
• Participation in other interventional clinical trials within 30 days
• Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
• Drug addiction
• Alcoholism or AIDS
• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
• History of serious allergic or allergy
• Patients who are not suitable to participate in the trial according to researchers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Nimotuzumab plus chemo-irradiation

Experimental group

Description:

Nimotuzumab，chemotherapy(cisplatin )，radiotherapy

Treatment:

Radiation: Radiotherapy

Drug: Nimotuzumab

Drug: cisplatin

Placebo plus chemo-irradiation

Placebo Comparator group

Description:

Placebo，chemotherapy(cisplatin)，radiotherapy

Treatment:

Radiation: Radiotherapy

Drug: Placebo

Drug: cisplatin