Lung cancer, esophageal cancer, gynecoma
Conditions
Interventions
Experimental group :Mecapegfilgrastim primary prevention
Control group :Observation and salvage treatment
Sponsors
Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Subjects diagnosed histologically and/or cytologically with lung cancer (non-small cell lung cancer, small cell lung cancer), esophageal cancer, and gynecoma (cervical cancer) shall be enrolled in the following limited stages: (1) Specific stages of lung cancer include: 1) Non-small cell lung cancer (primary, inoperable stage IIA, IIB, ?); 2) Small cell lung cancer (terminal stage, over T1-2, N0); (2) Esophageal cancer stages included: cT1b-4aN0M0, cT1-4aN+M0, cT1b-4bN0M0, cT1-4bN+M0; (3) The stages of gynecological tumors included cervical cancer (?B2, ?A2, ?B-?A); 3. ECOG score 0-2; 4. The main organs function normally and meet the following criteria: (1) The hematopoietic function of bone marrow was normal and there was no bleeding tendency (INR=75g/L; 2) White blood cell count (WBC) >=3.0x10^9/ L; 3) Neutrophil count (ANC) >=1.5x10^9/L; 4) Platelet count (PLT) >=80x10^9/L; (3) Liver function test shall meet the following criteria: 1) Alanine aminotransferase (ALT) <=2.5xULN; 2) Aspartate aminotransferase (AST) <=2.5xULN; 3) Total bilirubin (TBIL) <=2.5xULN; If it was due to liver metastasis, the above indexes should be <=5xULN; (4) Renal function examination shall meet the following standards: 1) Blood urea nitrogen (BUN) <=1.5xULN; 2) Serum creatinine (Cr) <=1.5xULN; 3) Blood uric acid (UA) <=1.5xULN; (5) No obvious cardiac or pulmonary dysfunction; 5. Subjects can tolerate concurrent chemoradiotherapy and have indications; 6. Subjects who had received induction chemotherapy for less than 2 cycles before enrollment could be included, but they must enter the screening period after induction chemotherapy; 7. Voluntarily participate in the clinical trial, understand the research procedures and be able to sign the informed consent in person; 8. Fertile female subjects shall undergo a serum pregnancy test that is negative within 72 hours prior to initial dosing. Fertile female subjects and male subjects with a fertile female partner must consent to use a highly effective method of contraception (such as oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) for a period of 90 days from signing the informed consent to the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Lactating patients; 2. Previous history of bone marrow transplantation and/or stem cell transplantation; 3. There are other hematological diseases affecting the hematopoietic function of bone marrow; 4. Allergic to study drugs or other G-CSF products or biological agents expressed by E. coli; 5. Patients with acute or active infection, or who have received systemic anti-infection therapy within 72 hours before chemotherapy; 6. Patients who had used G-CSF during induction chemotherapy before inclusion; 7. Those who plan to use immunotherapy simultaneously; 8. Patients who had received clinical trials of other drugs within 1 month before enrollment; 9. Concomitant diseases that, according to the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 10. Other conditions that the researchers judged unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3/4 neutropenia during concurrent chemoradiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of FN during concurrent chemoradiotherapy;Incidence of delayed chemoradiotherapy;Proportion of antibiotics used;Adverse events; | — |
Countries
China
Contacts
Public ContactXing Ligang
Cancer Hospital of Shandong First Medical University
Outcome results
None listed