Nausea and vomiting in patients receiving ADC therapy for the first time
Conditions
Interventions
Control group:HR20013 injection analog, fosaprepitant dimeglumine injection, palonosetron hydrochloride injection, dexamethasone acetate tablets, and dexamethasone acetate tablet analog.
Experimental group:HR20013 for injection, fosaprepitant dimeglumine injection simulant, palonosetron hydrochloride injection simulant, and dexamethasone acetate tablets.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age>=18 years, with no gender restriction; 2.Histologically or cytologically confirmed malignant solid tumor; 3.Planned to receive first-line ADC therapy containing a topoisomerase 1 inhibitor (Top1i) payload (no prior Top1i-based ADC treatment), scheduled for administration on Day 1 of the treatment cycle. If combined with other antineoplastic agents, the emetogenic risk of such agents shall not exceed that of Top1i-based ADCs; 4.Expected survival >= 3 months; 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6. Organ function is good and meets the following criteria: (1) Neutrophil count >= 1.5×10^9/L; (2) Hemoglobin >= 90 g/L; (3) Platelet count >= 90×10^9/L; (4) Total bilirubin = 50 ml/min; (7) ECG: QTc = 50%. 7. Female participants of childbearing potential, and male participants whose partners are of childbearing potential, must use one highly effective contraception method from the time of signing the informed consent until 6 months after the last dose of study medication, and avoid donating eggs/sperm. Female participants of childbearing potential must have a negative pregnancy test within 72 hours before randomization and must not be breastfeeding. 8. Clearly understand and voluntarily participate in the study, and sign the informed consent form personally.
Exclusion criteria
Exclusion criteria: 1. Received, or planned to receive between randomization and efficacy evaluation, full-body radiotherapy, abdominal (including diaphragm level and below), pelvic, whole brain and spinal, or head and neck radiotherapy within 7 days before randomization; 2. Planned to receive antitumor therapy including conventional paclitaxel (using castor oil as a solvent); 3. Took medications with potential antiemetic effects within 2 days before randomization: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), benzodiazepines, phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, sulpiride, etc.; (Note: preventive use for infusion reactions or allergic reactions according to ADC drug instructions is allowed); 4. Received systemic corticosteroid therapy within 7 days before randomization (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone), or sedative antihistamines (e.g., diphenhydramine); (Note: single use of steroids for prevention of contrast agent allergy and local or inhaled administration is allowed; preventive use for infusion reactions or allergic reactions according to ADC drug instructions is allowed); 5. Started using opioids (excluding codeine) within 7 days before randomization, or had dosage adjustments within 7 days; for patients already on opioids, if the dose has been stable for =8 days and tolerated without nausea or vomiting, enrollment is allowed. Additionally, patients with poor pain control or those who, according to investigator assessment, may need an increase in opioid dose during screening or treatment, are not eligible; 6. Used palonosetron within 14 days before randomization; 7. Used NK-1 receptor antagonists within 28 days before randomization. 8. Use of specific CYP3A4 substrates (terfenadine, cisapride, astemizole) or moderate/strong CYP3A4 inhibitors within 7 days before randomization, or use of strong CYP3A4 inducers or specific CYP2D6 substrates within 28 days before randomization; 9. Vomiting and/or dry heaving, nausea within 24 hours before randomization; 10. Symptomatic brain metastases, or any signs of brain metastases or increased intracranial pressure; 11. Uncontrolled serous cavity effusions, including pleural effusion, ascites, pericardial effusion (patients who achieved control after treatment and remained stable for =2 weeks can be included); 12. Severe cardiovascular diseases within 3 months before randomization, including but not limited to acute myocardial infarction, unstable angina, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (NYHA II–IV), serious cardiac conduction disorders (such as torsades de pointes); 13. Poorly controlled hypertension before randomization (two consecutive resting systolic BP =160 mmHg and/or diastolic BP =100 mmHg); 14. Active hepatitis B (HBV DNA =2000 IU/mL or 104 copies/mL), active hepatitis C (HCV-Ab positive and HCV-RNA above detection limit), acquired immunodeficiency syndrome (AIDS) or HIV positive, active syphilis infection; 15. Comorbidities unsuitable for taking dexamethasone, such as systemic infections, uncontrolled diabetes, etc., as judged by the investigator; 16. Presence of severe or uncontrolled diseases (e.g., diabetic ketoacidosis, gastrointestinal obstruction), where the i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving complete response on Days 1–14 of ADC treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of trial participants who achieved complete remission throughout the ADC treatment cycle;Proportion of trial participants with no significant nausea during days 1-14 of ADC treatment;Proportion of trial participants with no nausea during ADC treatment from day 1 to 14;Proportion of trial participants with no vomiting episodes from days 1 to 14 of ADC treatment;Proportion of trial participants without rescue medication from day 1-14 of ADC treatment;Proportion of trial participants fully protected by ADC treatment from Day 1 to 14;Proportion of participants who achieved complete control during ADC treatment from day 1 to 14;Time of treatment failure; | — |
Countries
China
Contacts
Public ContactHuiping Li
Beijing Cancer Hospital
Outcome results
None listed