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

Recruiting now · Not applicable

Conditions studied: Nausea With Vomiting Chemotherapy-Induced

In brief

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.

Key facts

Study ID

NCT06080880

Run by

Hubei Cancer Hospital

People needed

98

Starts

2023-12-01

Expected to finish

2027-11-01

Last updated by the study team

2024-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years, no gender limit;
• Pathologically or cytologically confirmed malignant solid tumors;
• Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
• TPS > 1 %(PD-1);
• 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]);
• 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])；
• Estimated survival time > 6 months；
• ECOG 0-1 points；
• Participants being informed and signed written consents.

You may not qualify if…

• Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
• Participants with other malignant tumors history previously;
• Inability to read, comprehend, and finish questionnaires;
• Allergic to the drugs included in this study.
• Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.

Where it is running

• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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