Trial Title:
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
NCT ID:
NCT05780294
Condition:
Nasopharyngeal Carcinoma
Leucogen
Chemotherapy
Myelosuppression
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Asparaginase
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
5-fu
Description:
5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Lobaplatin
Description:
30mg/m2, used on the 1st and 28th day of each cycle.
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Placebo
Description:
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.
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
leucogen
Description:
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.
Arm group label:
Experimental group
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.
Criteria for eligibility:
Criteria:
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);
- Serum albumin ≥2.8g/dL;
- Bilirubin ≤ 1.5x ULN, ALT and AST≤ 1.5x ULN; ALT and AST≤ 5x ULN if liver
metastasis was present;
- creatinine clearance ≥50mL/min
8. Women of non-surgical sterilization or reproductive age and sexually active men
enrolled in the study are required to use a medically effective form of
contraception (such as an intrauterine device [IUD], birth control pills or condoms)
for the duration of the study treatment and for at least 3 months after the last use
of Tamfu and for at least 6 months after the last use of chemotherapy; The serum or
urine HCG test of female patients of reproductive age who were not undergoing
surgical sterilization must be negative within 7 days prior to study enrollment. And
must be non lactation period;
9. Informed consent has been signed. -
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;
11. In the judgment of the researcher, the subject has other factors that may lead to
the termination of the study, such as other serious diseases (including mental
diseases) requiring combined treatment, serious abnormal laboratory examination,
family or social factors, which may affect the safety of the subject, or the
collection of test data and samples.
12. Women who are pregnant or breastfeeding, or who refuse/cannot accept medically
acceptable conditions. For women with potential pregnancy and sexually active men.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Start date:
April 1, 2023
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
JIANGSU JIBEIER PHARMACEUTICAL CO.,LTD
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05780294
