The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years, no gender limit;
2. Pathologically or cytologically confirmed malignant solid tumors;
3. Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade;
4. TPS \> 1 %(PD-1);
5. Adequate hematological function (leucocyte count ≥ 4000/μL \[to convert to ×109/L,multiply by 0.001\], hemoglobin ≥ 9.00 g/dL \[to convert to grams per liter, multiply by 10\], and platelet count ≥ 100 × 103/μL \[to convert to ×109/L, multiply by 1\]);
6. Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL/min/1.73 m2 \[to convert to millimeters per second per meter-squared, multiply by 0.0167\]);
7. Estimated survival time \> 6 months;
8. ECOG 0-1 points;
9. Participants being informed and signed written consents.
Exclusion Criteria:
1. Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
2. Participants with other malignant tumors history previously;
3. Inability to read, comprehend, and finish questionnaires;
4. Allergic to the drugs included in this study.
5. Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.
Primary outcome measure(s)
Complete response(CR) rate — Up to 6 weeks Defined as no emesis and no rescue therapy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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