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

Launched by HUBEI CANCER HOSPITAL · Oct 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called ondansetron can prevent nausea and vomiting caused by chemotherapy when combined with a treatment known as PD-1 blockade. Researchers want to find out if giving ondansetron once a week is more effective than giving it every three weeks. This is important because nausea and vomiting can be very uncomfortable side effects of cancer treatment, and finding the best way to manage these symptoms can help improve patients' quality of life during their treatment.

To participate in this trial, you need to be at least 18 years old and diagnosed with a solid tumor that will be treated with a specific type of chemotherapy called cisplatin along with PD-1 blockade. You should also be in good general health, with certain blood test results meeting specific criteria. If you decide to join, you will be randomly assigned to either receive ondansetron weekly or every three weeks, and you will be monitored for how well it works and any side effects. This trial is currently recruiting participants, and your participation could help improve treatment options for others experiencing similar challenges.

Gender

ALL

Eligibility 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.