Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second People's Hospital of Sichuan
• Collaborator: Biotech Pharmaceutical Co., Ltd.
• Treatments: Cisplatin; Docetaxel; Nimotuzumab

Criteria

Inclusion Criteria:

• Informed consent form

• Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx

• The tumor mass had to be measurable

• Karnofsky performance status ≥70

• Life expectancy estimated than 6 months

• Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；

• Hepatic: AST/ALT<1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;

• Renal: Creatinine<1.5 times ULN；

Exclusion Criteria:

• Known distant metastases

• Primary tumor and nodes received surgery(except of biopsy)

• Received other anti EGFR monoclonal antibody treatment

• Previous chemotherapy or radiotherapy

• Participation in other interventional clinical trials within 1 month

• Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)

• History of serious allergic or allergy

• History of Serious lung or heart disease

• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant