NCT06080880 Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade
| NCT ID | NCT06080880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hubei Cancer Hospital |
| Condition | Nausea With Vomiting Chemotherapy-Induced |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2023-12-01 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 blockade.
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.
Contact & Investigator
Guang Han, MD
PRINCIPAL INVESTIGATOR
Hubei Cancer Hospital, Wuhan, HuBei, China, 430079
Frequently Asked Questions
Who can join the NCT06080880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nausea With Vomiting Chemotherapy-Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06080880 currently recruiting?
Yes, NCT06080880 is actively recruiting participants. Contact the research team at hg7913@hotmail.com for enrollment information.
Where is the NCT06080880 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06080880 clinical trial?
NCT06080880 is sponsored by Hubei Cancer Hospital. The principal investigator is Guang Han, MD at Hubei Cancer Hospital, Wuhan, HuBei, China, 430079. The trial plans to enroll 98 participants.