Clinical trial · Interventional
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT03708822CI-TRIAL-00073097unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma
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 |
|---|---|---|---|
| Docetaxel and Cisplatin and Nimotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel and Cisplatin and Nimotuzumab
- description
- All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity.
- interventionNames
- Drug: Docetaxel and Cisplatin and Nimotuzumab
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- up to 18 weeks
- description
- the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1
Secondary outcomes (5)
- measure
- disease control rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proved nasopharyngeal carcinoma; * stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy; * 18-70 years; * without other malignancy; * had at least one measurable disease; * had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * estimated life expectancy exceeding 3 months; * adequate functions of the major organs. Exclusion Criteria: * allergic to docetaxel or cisplatin or nimotuzumab; * pregnant or lactating female; * patients received other clinical trails within 3 months; * had serious infections, comorbidities or vital organs dysfunction.
References
Publications (1)
- DERIVEDZou Q, Cao Y, Lai Y, Fang Y, Zhang Y, Liu P, Lu L, Wu H, Huang T, Su N, Li Z, Wang X, Tian X, Li L, Liu Y, Cai Q, Xia Y. Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial. BMC Med. 2025 May 6;23(1):264. doi: 10.1186/s12916-025-04103-0. PMID 40325445