RecruitingNot ApplicableNCT06080880

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

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


Sponsor

Hubei Cancer Hospital

Enrollment

98 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria5

  • 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.

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Interventions

DRUGOndansetron every 3 weeks

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

DRUGAprepitant

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

DRUGDexamethasone

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

DRUGOndansetron weekly

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


Locations(1)

Hubei Cancer Hospital

Wuhan, Hubei, China

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NCT06080880


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