NCT04890522

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

A Randomized, Open-label, Multicentre, Phase II/III Study of Low-dose Long-term Continuous Intravenous Infused 5-fluorouracil Versus Gemcitabine Combined With Cisplatin and JS001 as First-line Therapy for Metastatic Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 622 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.

Conditions

• Nasopharyngeal Carcinoma
• Metastasis
• Chemotherapy
• Immunotherapy
• Survival

Interventions

Type	Name	Description
DRUG	Triprilimab(JS001)	Maximum 6 cycles for combined therapy and maintenance for up to 2 years.
DRUG	Cisplatin	Maximum 6 cycles for combined therapy.
DRUG	5-Fluorouracil	Maximum 6 cycles for combined therapy.
DRUG	Gemcitabine	Maximum 6 cycles for combined therapy.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-12-31
• Completion: 2028-12-31
• First posted: 2021-05-18
• Last updated: 2021-05-18

Locations

1 site across 1 country: China