ClinicalTrials.gg
Not yet recruitingNCT07692451Updated Jul 9, 2026

Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting

A Phase 2 interventional study of Fosrolapitant and Palonosetron for injection in Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs), sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting

02

Conditions studied

  • Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)

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03

In context

Nausea

644 studies on the registry are indexed under Nausea; 85 are open to participants now.

This study's planned enrollment of 124 is above the median of 96 across 544 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 268 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

Exclusion criteria

Exclusion Criteria:

  1. 18 years of age or older, of either gender
  2. Has a diagnosed malignant tumor
  3. has never been treated with ADCs and is to receive the first course of ADCs
  4. Predicted of ≥ 3 months
  5. Has a performance status ( scale) of 0 to 1
  6. Adequate bone marrow, kidney, and liver function
  7. Women of must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
  8. Able and willing to provide a written
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Fosrolapitant and Palonosetron + dexamethasone + placebo

    Use this field to provide additional information about the arm, including a description of the intervention(s) administered.

    Drug: Fosrolapitant and Palonosetron for injection

  • Active comparator
    fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone

    Use this field to provide additional information about the arm, including a description of the intervention(s) administered.

    Drug: Fosrolapitant and Palonosetron for injection

Interventions

  • DrugFosrolapitant and Palonosetron for injection

    Drug pages: Fosrolapitant · Palonosetron

    • Experimental: Drug:Fosrolapitant and Palonosetron for injection Drug:Dexamethasone Drug: placebo • Active Comparator: Drug:HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug:Palonosetron injection Drug: Dexamethasone

06

What researchers measure

Primary outcomes

  1. Complete response rate

    Time frame: Within 14 days after ADC administration

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.

Of 34 phase 2 interventional studies under Nausea, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2026
First posted
Jul 9, 2026
StartEst.
Jul 15, 2026
Primary completionEst.
Jul 15, 2027
CompletionEst.
Sep 30, 2027
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07692451
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Jul 15, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

li huiping chief physician
Contact
huipingli2012@hotmail.com
+86-13811012595

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Fosrolapitant · Palonosetron

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