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

ConditionNausea With Vomiting Chemotherapy-Induced
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHubei Cancer Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ondansetron every 3 weeks

    Drug

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

  • Aprepitant

    Drug

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

  • Dexamethasone

    Drug

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

  • Ondansetron weekly

    Drug

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

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Ondansetron every 3 weeks combined with aprepitant and dexamethasoneExperimental treatment 3 interventions
Group B: Ondansetron weekly combined with aprepitant and dexamethasoneExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete response(CR) rate

Defined as no emesis and no rescue therapy

Time frame
Up to 6 weeks

Secondary outcomes

1

The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.

The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea (defined as no or mild nausea), and the mean time to first emetic episode.

Time frame
Assessed every week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hubei Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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