Malignant Tumor
Conditions
Interventions
Group A:None
Group B:Preventive use of dexamethasone mouthwash
Sponsors
Beijing Luhe Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed malignancy with initial treatment containing Sacituzumab Tirumotecan 2. Age 18–80 years, both males and females are eligible 3. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Measurable lesions must not have received prior local therapy (e.g., radiotherapy).Lesions within previous radiotherapy fields are acceptable as target lesions if progression is confirmed and RECIST v1.1 criteria are met 4. ECOG performance status: 0–2 5. Anticipated life expectancy >=12 weeks 6. Adequate organ function, defined as: Hematological: a. Hemoglobin (HB) >=90 g/L b. Absolute neutrophil count (ANC) >=1.5 × 10?/L c. Platelet count (PLT) >=80 × 10?/L Biochemical: a. Albumin (ALB) >=30 g/L b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 mL/min (Cockcroft-Gault formula) 7. Voluntary participation: Subjects must sign a written informed consent form, demonstrate good compliance, and cooperate with follow-up 8. Oral hygiene compliance: Ability to maintain oral hygiene during the treatment period
Exclusion criteria
Exclusion criteria: 1. Prior treatment with free or other formulations of topoisomerase I inhibitors 2. Known HIV-positive status 3. Cardiovascular history within 6 months before the first dose:Unstable angina, myocardial infarction, or congestive heart failure.Clinically significant arrhythmia requiring antiarrhythmic therapy (except stable atrial fibrillation).Left ventricular ejection fraction (LVEF) =4 weeks. 8. Planned major surgery during the study period (minor procedures not delaying study treatment are permitted). 9. Live vaccination within 30 days before the first dose 10. Comorbidities that may confound study interpretation or impede protocol compliance, as judged by the investigator. 11. Hypersensitivity to any component of the study treatment or excipients. 12. Investigator’s discretion for ineligibility based on clinical risks. 13. Oral conditions:Current or history of oral mucositis.Unhealed dental/oral surgery wounds.Acute dental/jaw diseases requiring surgical intervention.Planned invasive dental procedures during the study.Active pulpitis or periodontitis at screening. 14. Uncontrolled diabetes (Grade >=3 per NCI-CTCAE v5.0) within 6 months before the first dose. 15. Prior neck radiotherapy within 6 months before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of stomatitis in Group A and Group B patients after 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Median Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactPeihua Zhang
Beijing Luhe Hospital Affiliated to Capital Medical University
Outcome results
None listed