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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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

NCT05780294•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years old and ≤60 years old；
•2. Pathological diagnosis of stage IV, recurrent or distant metastatic nasopharyngeal carcinoma；
•3. Patients with stage IV, metastatic (including primary and secondary) or recurrent nasopharyngeal carcinoma who are not suitable for local treatment, local treatment mainly refers to measures related to anti-tumor therapy, including surgery, radiofrequency ablation, transhepatic artery chemoembolization (TACE), radiotherapy (excluding bone metastases, local moderate amount of radiation therapy for symptom relief without affecting hematological indicators)；
•4. Karnofsky functional status score should be at least 70 points (the decline of functional status score caused by tumor should be appropriately relaxed after the judgment of the researcher, and the minimum score should be no less than 50 points. );
•5. At least 1 measurable lesion according to RECIST1.1 assessment criteria, measurable lesion should not have received local treatment such as radiotherapy;
•6. Expected survival ≥3 months;
•7. The function of vital organs meets the following requirements (not allowed within 14 days before screening . May use any blood components, cell growth factors, leukoplast, platelets Drugs, anemia correction drugs) :
•* Neutrophil absolute count (ANC) ≥1.5×109/L
•* Platelet ≥100×109/L;
•* Hemoglobin ≥8.0g/ dL (note: Hemoglobin ≥8.0g/ dL can be achieved through blood transfusion or other intervention);
+5 more criteria

Exclusion Criteria

•1. Have a history of allergy to 5-FU, cisplatin and leucogen;
•2. Received elevated blood therapy 14 days prior to screening (including cytokines, leuk-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc.)
•3. Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
•4. The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
•5. Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy to achieve immunosuppression (dose \>10mg/ day prednisone or Other equally effective hormones) and continued to be used within 2 weeks prior to enrollment.
•6. The subject has previous or co-existing malignancies (except those that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid);
•7. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: # HEART failure of NYHA grade 2 or above # unstable angina pectoris # myocardial infarction within 1 year # clinically significant ventricular arrhythmias or ventricular arrhythmias requiring treatment or intervention;
•8. Subjects have active infection or have unexplained fever \>38.5 degrees during screening but before the first dose (the investigator judged that the subjects' fever due to tumor could be included in the study);
•9. Subjects with congenital or acquired immune deficiency (e.g. HIV infected), or active hepatitis (reference: HBsAg, anti-HBS, HBeAg, anti-HBC, anti-HBE, HBV DNA≥10#/ml, liver cell transaminase, etc.); Hepatitis C reference: HCV antibodies and HCVRNA);
•10. The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
+3 more criteria

Locations (1)

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

Guangzhou, Guangdong, China

Key Dates

Start Date

April 1, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 1, 2029

Last Updated

March 22, 2023

Enrollment

132

ESTIMATED participants

Conditions

Nasopharyngeal CarcinomaLeucogenChemotherapyMyelosuppression

Interventions

5-fu

DRUG

Lobaplatin

DRUG

Placebo

DRUG

leucogen

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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