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Clinical Trials in China / NCT06080880
Recruiting Not applicable

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

NCT06080880 · tracked via the Priya Life Science China tracker
Sponsor
Hubei Cancer Hospital
Phase
Not applicable
Started
2023-12-01
Last updated
2024-02-29

Condition(s) studied

Nausea With Vomiting Chemotherapy-Induced

Investigational drug(s) / intervention(s)

Ondansetron every 3 weeksAprepitantDexamethasoneOndansetron weekly

Ondansetron every 3 weeks: Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks

Aprepitant: aprepitant, Po, 125mg/d, 1day' application every 3 weeks

Dexamethasone: dexamethasone, iv, 10mg/d, 1day' application every 3 weeks

Ondansetron weekly: Ondansetron, Po, 24mg/d, 3 days' application weekly

Study 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.

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)

Trial sites (1)

FacilityCityRegionStatus
Hubei Cancer Hospital Wuhan Hubei Recruiting

More Hubei Cancer Hospital trials in China

Official registry record

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.

View NCT06080880 on ClinicalTrials.gov ↗ ← All trials in China