NCT05780294

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet Whole-course Management Assisted by PFLL Chemotherapy in the Treatment of Stage IV, Recurrent or Metastatic NPC

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet Whole-course Management Assisted by Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-fluorouracil Chemotherapy in the Treatment of Stage IV, Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Toxic and side effects during and after chemoradiotherapy for nasopharyngeal carcinoma seriously affect patients' treatment compliance and long-term quality of life. Active and effective prediction, prevention and management of toxic and side effects is an important element to improve the prognosis of patients. Leucogen has the ability to promote the growth and maturation of granulocytes in the bone marrow and the proliferation of leukocytes, and is widely used in radiation therapy and chemotherapy-induced leukopenia in malignant carcinomas. In addition, leucogen may have potential anticancer synergistic effects. Therefore, based on the application prospect of leucogen in preventing myelosuppression during chemotherapy for solid tumors, the study was designed to investigate the efficacy and safety of leucogen versus placebo on leukocyte and platelet whole-course management assisted by platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil chemotherapy in the treatment of stage IV, recurrent or metastatic nasopharyngeal carcinoma.

Conditions

• Nasopharyngeal Carcinoma
• Leucogen
• Chemotherapy
• Myelosuppression

Interventions

Type	Name	Description
DRUG	5-fu	5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
DRUG	Lobaplatin	30mg/m2, used on the 1st and 28th day of each cycle.
DRUG	Placebo	2 tablets/dose 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, 3 tablets/dose 3 times daily during chemotherapy, and continued to be given orally 2 tablets/dose 3 times daily for 4 weeks after the end of chemotherapy.
DRUG	leucogen	40 mg/dose was used 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, and 60 mg/dose was used 3 times daily during chemotherapy, and 40 mg/dose was continued orally 3 times daily for 4 weeks after the end of chemotherapy.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-12-31
• Completion: 2029-12-01
• First posted: 2023-03-22
• Last updated: 2023-03-22

Locations

1 site across 1 country: China