NCT04073784

Gemcitabine Combined With Apatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.

An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Gemcitabine Combined With Apatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma.

Detailed description

This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma. Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine combined with Aptinib and Toripalimab	Gemcitabine injection, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles. Apatinib for oral administration, 250mg, once a day. Apatinib maintenance. Toripalimab injection, 240mg, Day 1 each 21day. Toripalimab maintenance.

Timeline

• Start date: 2019-06-08
• Primary completion: 2022-04-01
• Completion: 2024-04-01
• First posted: 2019-08-29
• Last updated: 2022-04-26

Locations

1 site across 1 country: China