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NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens

NCT06331520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2026-04-09

No results posted yet for this study

Summary

The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Conditions

  • Chemotherapy-induced Nausea and Vomiting
  • Highly Emetogenic Chemotherapy

Interventions

DRUG

Netupitant / Palonosetron Oral Capsule [Akynzeo]

Akynzeo is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist \[NK1 RA\]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist \[5-HT3 RA\]).

DRUG

Olanzapine

Olanzapine is an effective antipsychotic drug used in psychiatry to treat psychoses, especially schizophrenia and schizoaffective disorders. It belongs to the 2nd generation antipsychotics, its mechanism of action ranks among multireceptor antagonists (MARTA); it affects the dopamine, serotonin, adrenaline, histamine, and muscarinic systems.

DRUG

Dexamethasone Oral

synthetic glucocorticoids

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Jian Zhang, MD,PhD · Phase I Unit, Fudan University Shanghai Cancer Center, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-08-01
Completion
2025-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331520 on ClinicalTrials.gov