Gastrointestinal neoplasm
Conditions
Interventions
Single arm group:Patients participate in two cycles of dosing
Sponsors
the Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with gastric cancer and intestinal cancer confirmed by histopathology; 2. Patients who are evaluated by the investigator to accept the XELOX chemotherapy regimen; 3. ECOG 0-1 points (see Appendix 1); 4. Aged 18-70 years old; 5. It is expected to complete 2 cycles of the same adjuvant chemotherapy as planned; 6. Normal bone marrow hematopoietic function, no bleeding tendency (INRx1.5); 7. Routine blood examination must meet: Hb>=90g/L; WBC>=3.5x10^9/L; ANC>=1.5x10^9/L; PLT>=80x10^9/L; 8. Blood biochemical tests must meet: TBIL= 50ml/min; 9. Cardiac ultrasound examination showed that left ventricular ejection fraction (LVEF) >= 50%; 10. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment and the result is negative, and are willing to use appropriate methods of contraception during the test and within 8 weeks after the last drug administration; 11. According to the judgment of the investigator, the trial protocol can be complied with;Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the test drugs in this study; 2. Those who suffer from mental or nervous system disorders and cannot cooperate; 3. Pregnant or lactating female patients; 4. Those who are considered unsuitable for inclusion by the researchers; 5. History of other malignant tumors within 5 years (except skin basal cell carcinoma or cervical carcinoma in situ); 6. Unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; participated in clinical trials within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3 and 4 neutropenia;Incidence and severity of all adverse events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia (FN);Incidence of Chemotherapy Dose Modifications Due to Neutropenia;Proportion of hospitalized patients due to neutropenia;Antibiotic use due to neutropenia;Incidence of short-acting WBC-elevating rescue therapy; | — |
Countries
china
Contacts
Public ContactLiu Yibing
the Fourth Hospital of Hebei Medical University
Outcome results
None listed