NCT06886347 Metastatic Nasopharyngeal Carcinoma
| NCT ID | NCT06886347 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chen Xiaozhong |
| Condition | Metastatic Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 47 participants in total. It began in 2023-07-07 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study. 10. The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study. Exclusion Criteria: 1. ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded. 2. Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing. 3. Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration. 4. Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance). 5. Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease. 6. Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy. 7. Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism. 8. Previously received anti angiogenic therapy. 9. According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06886347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06886347 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06886347 currently recruiting?
Yes, NCT06886347 is actively recruiting participants. Contact the research team at chenxz@zjcc.org.cn for enrollment information.
Where is the NCT06886347 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06886347 clinical trial?
NCT06886347 is sponsored by Chen Xiaozhong. The trial plans to enroll 47 participants.