Phase 1 Study of Penpulimab with Gemcitabine and Anlotinib for Treating Metastatic Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a treatment plan combining Penpulimab, Gemcitabine, and Anlotinib for people with metastatic nasopharyngeal carcinoma. The main goal is to measure how long patients can live without the cancer worsening, known as progression-free survival. This is a Phase 1 clinical trial designed to explore these treatments in this patient group. The treatment involves intravenous Penpulimab infusions of 200 mg on the first day of each 3-week cycle. Gemcitabine is given by intravenous infusion at 1000 mgm2 on the 1st and 8th days of each cycle, for 4 to 6 cycles. Anlotinib capsules are taken orally once daily on an empty stomach for 2 weeks, followed by a 1-week break, repeating every 3 weeks. This combination regimen is being studied in an open-label, single-arm format. Participants will be closely monitored from baseline up to 2 years. Researchers will assess tumor response, overall survival, quality of life, and other health markers such as PD-L1 expression and blood Epstein-Barr virus levels. Regular visits will include physical exams, laboratory tests, and imaging to track treatment effects and safety. Participants are expected to follow the treatment schedule and attend scheduled assessments throughout the study period.

Metastatic Nasopharyngeal Carcinoma