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A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Local Advanced Esophageal Squamous Cell Carcinoma

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Trial Information

A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Response rate of Nimotuzumab combined with chemo-irradiation

Outcome Time Frame:

2 months after radiotherapy

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

BT-ESO-1001

NCT ID:

NCT01232374

Start Date:

August 2010

Completion Date:

February 2014

Related Keywords:

  • Local Advanced Esophageal Squamous Cell Carcinoma
  • Nimotuzumab
  • local advanced esophageal squamous cell carcinoma
  • chemo-irradiation
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

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