Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06080880

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

Led by Hubei Cancer Hospital · Updated on 2024-02-29

98

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Pathologically or cytologically confirmed malignant solid tumors
  • Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade
  • Tumor proportion score greater than 1% for PD-1
  • Adequate hematological function: leucocyte count ≥ 4000/µL, hemoglobin ≥ 9.00 g/dL, platelet count ≥ 100 × 10³/µL
  • Hepatic function with alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of normal
  • Renal function with creatinine clearance ≥ 60 mL/min/1.73 m²
  • Estimated survival time more than 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Informed consent signed by participant
Not Eligible

You will not qualify if you...

  • Nausea or vomiting caused by reasons other than chemotherapy and PD-1 blockade
  • History of other malignant tumors
  • Inability to read, understand, and complete questionnaires
  • Allergy to any drugs used in this study
  • Use of antiemetic drugs within 24 hours before the first dose of study medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

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Research Team

G

Guang Han, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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