Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Recurrence

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Asparaginase

Chemotherapy:

5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Lobaplatin: 30mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 6 cycles, a total of 12 months.

Drug: Placebo After diagnosis of stage IV, recurrent or metastatic nasopharyngeal carcinoma (within 3 weeks before treatment), placebo tablets were started,) 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. In case of grade III-IV myelosuppression during treatment, recombinant human granulocyte-stimulating factor injection (manufactured by Qilu Pharmaceutical Co., Ltd.) was given again at 2\~5ug/kg, subcutaneously once daily, and the clinical trial was terminated.

Chemotherapy:

5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Lobaplatin: 30mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 6 cycles, a total of 12 months.

Drug: Leucogen After the diagnosis of stage IV, recurrent or metastatic nasopharyngeal carcinoma (within 3 weeks before treatment), oral leucogen tablets (manufactured by JIANGSU JIBEIER PHARMACEUTICAL CO.,LTD, 20 mg/tablet) were started and 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. In case of grade III-IV myelosuppression during treatment, recombinant human granulocyte-stimulating factor injection (manufactured by Qilu Pharmaceutical Co., Ltd.) was given again at 2\~5ug/kg, subcutaneously once daily, and the clinical trial was terminated.

5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.

5-fu

30mg/m2, used on the 1st and 28th day of each cycle.

Lobaplatin

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.

Placebo

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.

leucogen

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.

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

From the beginning of treatment to the onset of myelosuppression

JIANGSU JIBEIER PHARMACEUTICAL CO.,LTD

Sun Yat-sen University

Principal Investigator

Spots Global Cancer Trial Database for leucogen

Every month we try and update this database with for leucogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for leucogen

Every month we try and update this database with for leucogen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for leucogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.