Metastatic Nasopharyngeal Carcinoma
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
| Condition(s) | Metastatic Nasopharyngeal Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint. |
| Who can participate | Inclusion Criteria: 1. The participants voluntarily signed an informed consent form. 2. Age of ≥ 18 years and ≤ 75 years at the time of enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. xpected survival of ≥ 3 months. 5. Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th). 6. Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy. 7. At least one measurable tumor lesion per RECIST 1.1 criteria. 8. Adequate organ function. 9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chen Xiaozhong |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2023-07-07 |
| NCT ID | NCT06886347 |
| Official listing | https://clinicaltrials.gov/study/NCT06886347 |