Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade

• Status: Recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hubei Cancer Hospital
• Treatments: Aprepitant; Dexamethasone; Ondansetron

Criteria

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.