A Phase 2 interventional study of Nimotuzumab and Placebo in Squamous Cell Carcinoma, sponsored by Biotech Pharmaceutical Co., Ltd.. Status unknown at 17 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-20.
Sponsored by Biotech Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 144 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Biotech Pharmaceutical Co., Ltd. is the lead sponsor of 31 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Nimotuzumab，chemotherapy(cisplatin )，radiotherapy
Drug: Nimotuzumab · Drug: cisplatin · Radiation: Radiotherapy
Placebo，chemotherapy(cisplatin)，radiotherapy
Drug: Placebo · Drug: cisplatin · Radiation: Radiotherapy
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)
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)
Also known as: Nimotuzumab, Placebo
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).
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)
Response rate of Nimotuzumab combined with chemo-irradiation
Time frame: 2 months after radiotherapy
1-yr overall survivals
Time frame: 1 year
2-yr overall survival
Time frame: 2 year
3-yr overall survival
Time frame: 3 years
Local progression-free survival
Time frame: 3 years
Disease progression-free survival
Time frame: 3 years
Distant metastasis rate
Time frame: 3 years
Number and grade of Participants with Adverse Events
Time frame: 6 months
Quality of life
Time frame: 3 years
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Biotech Pharmaceutical Co., Ltd.