Status:
RECRUITING
Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade
Lead Sponsor:
Hubei Cancer Hospital
Conditions:
Nausea With Vomiting Chemotherapy-Induced
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 bloc...
Detailed Description
Nausea and vomiting have become the most common and intolerant adverse events in patients receiving chemotherapy, which cause substantial impairments in human functions and quality of life. In some se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06080880
Start Date
December 1 2023
End Date
November 1 2027
Last Update
February 29 2024
Active Locations (1)
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1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079