Squamous Cell Carcinoma
Conditions
Keywords
Nimotuzumab, local advanced esophageal squamous cell carcinoma, chemo-irradiation
Brief summary
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.
Detailed 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.
Interventions
DRUGNimotuzumab
200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
DRUGPlacebo
4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
DRUGcisplatin
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
RADIATIONRadiotherapy
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks. Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
Sponsors
Biotech Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of Nimotuzumab combined with chemo-irradiation | 2 months after radiotherapy |
| 1-yr overall survivals | 1 year |
| 2-yr overall survival | 2 year |
| 3-yr overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Local progression-free survival | 3 years |
| Disease progression-free survival | 3 years |
| Distant metastasis rate | 3 years |
| Number and grade of Participants with Adverse Events | 6 months |
| Quality of life | 3 years |
Countries
China
Outcome results
None listed