By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.

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

Details

• Lead Sponsor: Guiyang Medical University
• Treatments: Cisplatin; Nimotuzumab

Criteria

Inclusion Criteria:

1. The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification).

2. The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).

3. Age: Between 18 to 70.

4. EGFR, which is performed by biopsy immunohistochemical examination, shows positive.

5. Functional Status: Karnofsky Scale (KPS) > 70.

6. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.

7. Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) < 2.5 x ULN and bilirubin < ULN.

8. Normal Renal Function: creatinine clearance > 60 ml/min.

9. The patient must be informed of the basic content of the study and sign an informed consent.

Exclusion Criteria:

1. Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ.

2. Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).

3. Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).

4. Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).

5. Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.