Chemotherapy-Induced Myelosuppression
Conditions
Interventions
Locally Advanced Nasopharyngeal Carcinoma Cohort:Trilaciclib 240 mg/m2, administered in combination with chemotherapy, via intravenous injection within 4 hours prior to chemotherapy. For multi-day che
the interval between consecutive administrations of trilaciclib shall not exceed 28 hours.
Locally Advanced Cervical Carcinoma Cohort:Trilaciclib 240 mg/m2, administered in combination with chemotherapy, via intravenous injection within 4 hours prior to chemotherapy. For multi-day chemother
Locally Advanced Esophageal Carcinoma Cohort:Trilaciclib 240 mg/m2, administered in combination with chemotherapy, via intravenous injection within 4 hours prior to chemotherapy. For multi-day chemoth
Sponsors
The First Affiliated Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, male or female; 2. Patients with pathologically and radiologically confirmed locally advanced nasopharyngeal carcinoma or cervical carcinoma who require induction chemotherapy combined with concurrent chemoradiotherapy, and patients with pathologically confirmed locally advanced esophageal carcinoma who require concurrent chemoradiotherapy. Targeted therapy and/or immunotherapy may be included in the chemotherapy regimens. 3. Karnofsky Performance Status (KPS) score = 80-90, expected survival time = 3 months, and follow-up observation for more than 3 months; 4. No significant abnormalities in blood routine, liver and kidney function, myocardial enzymes, and electrocardiogram (ECG): (1) Hemoglobin >= 100 g/L (for females), >= 110 g/L (for males); (2) Neutrophil count >= 2×10?/L; (3) Platelet count >= 100×10?/L; (4) Creatinine = 60 mL/min (calculated by the Cockcroft-Gault formula); (5) Total bilirubin = 30 g/L; 5.Subjects voluntarily participate in this study, with good compliance, and cooperate with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Contraindications to radiotherapy or chemotherapy; 2. Patients allergic to biological agents or components of trilaciclib; 3. Received any cytotoxic chemotherapy or PD-1/PD-L1 inhibitor therapy (if applicable) within <= 21 days before the first administration of the study drug; 4. Received any study drug within <= 30 days before the first administration of the study drug; 5. Complete intestinal obstruction; 6. Severe cardiovascular system diseases; 7. Infectious diseases; 8. Bleeding tendency or coagulation dysfunction; 9. Unstable vital signs; 10. Cachexia; 11. Subjects deemed by the investigator to be excluded from the study. For example, according to the investigator's judgment, the subject has other factors that may force the premature termination of the study, such as other serious diseases (including mental illnesses) requiring combined treatment, severe abnormal laboratory test results, or family/social factors that may affect the subject's safety or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who did not develop grade III or higher neutropenia during induction chemotherapy combined with concurrent chemoradiotherapy and within 3 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Febrile Neutropenia (FN) During Treatment and Within 3 Weeks After Treatment;Proportion of Salvage Therapy with Granulocyte Colony-Stimulating Factor (G-CSF) During Treatment and Within 3 Weeks After Treatment; | — |
Countries
China
Contacts
Public ContactLina Zhao
The First Affiliated Hospital, Air Force Medical University
Outcome results
None listed