Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07482891

An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC

Led by Shanghai 6th People's Hospital · Updated on 2026-04-30

200

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.

CONDITIONS

Official Title

An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, any gender, voluntarily signed informed consent with good compliance
  • Histologically or cytologically confirmed malignant solid tumor
  • No prior exposure to any chemotherapeutic agents
  • First-time participants scheduled for multi-day highly emetogenic chemotherapy lasting at least 3 days
  • No impairment in speech, hearing, or comprehension
  • Expected survival of at least 3 months
  • ECOG performance status of 0 to 1
  • Adequate organ function including neutrophil count 1.5 x 10^9/L, hemoglobin 90 g/L, platelet count 100 x 10^9/L
  • Total bilirubin 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase and alanine aminotransferase 2.5 times ULN if no liver metastases, up to 5 times ULN if liver metastases
  • Serum creatinine 1.5 times ULN or creatinine clearance 50 ml/min
  • Electrocardiogram QTc 450 ms (males), QTc 470 ms (females)
  • Echocardiogram left ventricular ejection fraction (LVEF) 50%
  • Female participants of childbearing potential and male partners must use effective contraception from consent until 6 months after last dose
  • Female participants of childbearing potential must have negative pregnancy test within 72 hours prior to enrollment and must not be breastfeeding
Not Eligible

You will not qualify if you...

  • Symptomatic brain metastases or symptoms suggesting brain metastases or intracranial hypertension
  • Radiotherapy within 7 days before enrollment or extensive radiotherapy within 3 months, or planned radiotherapy during study
  • Use of antiemetic medications with effects within 2 days prior to enrollment
  • Initiation of benzodiazepine or opioid therapy within 2 days prior to enrollment (excluding certain sedatives)
  • Morphine use started within 7 days before enrollment (except stable doses)
  • Systemic corticosteroids or sedating antihistamines within 7 days before enrollment (except single-dose or topical/inhaled)
  • Use of palonosetron within 14 days before enrollment
  • Use of NK-1 receptor antagonists within 28 days before enrollment
  • Vomiting, retching, or nausea within 24 hours before enrollment
  • Poorly controlled serosal effusions unless stable for at least 2 weeks
  • Severe cardiovascular disease within 3 months before enrollment
  • Active hepatitis B or C, AIDS, HIV, or syphilis infection
  • Conditions preventing dexamethasone use such as active infections or uncontrolled diseases
  • Known allergies or contraindications to study medications
  • Participation in another clinical trial within 30 days prior to enrollment
  • Other conditions making the participant unsuitable for the study as judged by the investigator

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

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China, 200233

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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