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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

April 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 1, 2029

Conditions
Nasopharyngeal CarcinomaLeucogenChemotherapyMyelosuppression
Interventions
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.

Trial Locations (1)

510060

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

JIANGSU JIBEIER PHARMACEUTICAL CO.,LTD

UNKNOWN

lead

Sun Yat-sen University

OTHER

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 | Biotech Hunter | Biotech Hunter