Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
| First People's Hospital of Foshan | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Guangxi Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF+ Nimotuzumab | Experimental | Patients treated with cisplatin and 5-Fu combined with nimotuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin and 5-Fu combined with nimotuzumab | Drug | DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | To be determined by measurement of target lesions according to RECIST criteria | study period of 19 Months |
| Progression free survival | Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause. | 19 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit. | 19 Months |
| Quality of life | Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30689735 | Derived | Zhao C, Miao J, Shen G, Li J, Shi M, Zhang N, Hu G, Chen X, Hu X, Wu S, Chen J, Shao X, Wang L, Han F, Mai H, Chua MLK, Xie C. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: a multicentre, open-label, phase II clinical trial. Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020. |
| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| OTHER |
| Guangzhou Medical University | OTHER |
| Hubei Cancer Hospital | OTHER |
| Hunan Provincial Cancer Hospital | UNKNOWN |
| Hangzhou Cancer Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Tongji Hospital | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
| Wuhan University | OTHER |
| Zhejiang Cancer Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 8 Months |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |