NCT06886347

Metastatic Nasopharyngeal Carcinoma

Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Chen Xiaozhong · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Penplimab Injection	Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
DRUG	Antitinib Hydrochloride Capsules	10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
DRUG	Gemcitabine	Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

Timeline

• Start date: 2023-07-07
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: China