Clinical trial · Interventional
Anti-EGFR Therapy Plus IMRT Concurrent Chemoradiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy
IMRT Combined With Concurrent Chemotherapy and Anti-EGFR Monoclonal Antibody for Locally Advanced Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy: a Multicenter Prospective Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with concurrent chemotherapy and anti-EGFR monoclonal antibody in locally advanced nasopharyngeal carcinoma with induced chemotherapy resistance. Eligibility criteria include histologically confirmed locally advanced NPC according to the American Joint Committee on Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count, normal hepatic function and normal renal function. Exclusion criteria include previous radiotherapy, a history of any other type of malignancy; pregnancy or lactation; allergy to anti-EGFR monoclonal antibody; obvious dysfunction of liver, renal, cardiac or lung function; uncontrolled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases, and patients with mental disorders affecting patient participation in trial judgement. The full-set pretreatment evaluation will be performed to every patient. All patients in this study will receive intensity-modulated radiation therapy (IMRT). The primary endpoints of this study is progression-free survival (PFS) and adverse events (AE) rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab (CTX) or nimotuzumab (NTZ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-EGFR arm
- description
- In the induction chemotherapy phase, TP regimen (Docetaxel 75mg/m2, D1 + DDP 25mg/m2, D1-3, repeat every 3 weeks) or GP regimen (Gemcitabine 1.0g/m2, D1, 8 + DDP 25mg/m2 , D1-3, repeat every 3 weeks) will be used. Cetuximab 400mg/m2 will be used one week before radiotherapy and 250mg/m2/week during IMRT, or nimotuzumab 200mg/week; meanwhile, cisplatin 80mg/m2 will be used every 3 weeks.
- interventionNames
- Drug: cetuximab (CTX) or nimotuzumab (NTZ)
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 3-year PFS
- description
- PFS is calculated from the date of the enrollment to the date of disease progression or the date of death for any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed locally advanced NPC; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Normal complete blood count; * Normal hepatic function; * Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). Exclusion Criteria: * Previous radiotherapy; * A history of any other type of malignancy; * Pregnancy or lactation; * Allergy to anti-EGFR monoclonal antibody; * Obvious disfunction of liver, renal, cardiac or lung function; * Un controlled infection; * Systemic metastasis or distant metastasis; * Patients with severe gastrointestinal diseases; * Patients with mental disorders affecting patient participation in trial judgement.
References
Publications (0)
Data not yet available