esophageal cancer
Conditions
Interventions
Experiment Group:Netopitampalonosetron
Sponsors
the Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 years old; 2. Esophageal malignancies confirmed by histopathology or cytology; The area of radiotherapy was mainly in the upper abdomen. 3. ECOG score of physical status =2 points; 4. Life expectancy =3 months; 5. Subjects voluntarily and strictly abide by the requirements of the study protocol and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received any known or potential antiemetic medication within 24 hours of the first day, or had symptoms of vomiting, retching or mild nausea within 24 hours of the first day; 2. Pregnant or lactating women; 3. Use of CYP3A4 inducer within 4 weeks and CYP3A4 substrate within 1 week prior to study initiation Or strong, moderate CYP3A4 inhibitors; 4. Hypocalcemia or any other condition that may cause vomiting; 5. Factors that significantly affect oral drug absorption, such as chronic diarrhea and intestinal obstruction; 6. The subject has an allergic reaction to netopitampalonosetron capsules or any of its excipients; 7. The patient has a medical record of participating in a clinical study of any other investigational drug or medical device within 30 days prior to medication, except for observational studies; 8. In the investigator's opinion, there are any other factors that are not suitable for inclusion or affect participation in or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of patients with complete response (no vomiting and no rescue treatment) during radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of patients with complete response (no vomiting and no rescue treatment) in the first two weeks;;Incidence of patients with complete response (no vomiting and no rescue treatment) in the last two weeks;;Incidence of patients without vomiting in the full course of treatment;Incidence of patients receiving rescue treatment in the whole course of treatment;;The effect of the full course of nausea and vomiting on the patients' activities of daily living (vomiting life function index Questionnaire (FLIE) assessment;; | — |
Countries
China
Contacts
Public ContactMa Hongbing
the Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed