Leukopenia caused by chemotherapy and radiotherapy in patients with malignant tumors
Conditions
Interventions
rhGM-CSF group:administer recombinant hGM-CSF orally
placebo-control group:administer recombinant hGM-CSF orally
Sponsors
Second Affiliated Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The patients must be confirmed to be malignant tumor.The patients have not received chemotherapy or radiotherapy in the past.TP proposed programme of chemotherapy or radical chemotherapy.Aged 18-70 years old, ECOG 0-2 score points. Expected to survive more than 3 months.The major organs function is in the normal range.Seven days before trial: WBC>=4.0*10^9/L; ANC >=1.5*10^9/L; PLT>=100*10^9/L; Hb>=100g/L; Serum Cr <= normal high limit (ULN); serum bilirubin <=ULN; ALT/AST <=2.5 ULN.Subjects signed informed consent. Good compliance
Exclusion criteria
Exclusion criteria: Subjects had uncontroled infection or serious illness and the researchers consider that the subjects not suit for the study. Subjects may have received treatment or drugs affecting the immune system, the hematopoietic system such as immunosuppressive drugs, EPO, TPO, and other treatment in the past. Subjects received any other medication in the past four weeks. Allergic to the researched drug. Pregnancy and breast-feeding women. Major organ failure, such as decompensated heart, lung, liver, renal failure. With other anomalies: such as mental disorder, drug and alcohol abuse. Researchers do not consider them appropriate to participate in this study. Allergic to shrimp, crab. Liver cancer, pancreatic cancer patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The counts of WBC; | — |
Countries
China
Contacts
Public ContactYaozhou Zhang
Outcome results
None listed