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New hope for kids with rare cancer: sirolimus combo shows promise

NCT ID NCT06341998

Disease control Sponsor: Shandong First Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new combination of drugs (sirolimus plus chemotherapy) in 32 children with recurrent or refractory yolk sac tumors, a rare type of germ cell tumor. The goal was to see if the combination could shrink tumors and improve survival. The treatment was given in cycles over several weeks, with regular monitoring of tumor markers and imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus combined with nab-paclitaxel, ifosfamide, and carboplatin
What this could lead to
If successful, this combination could offer a new treatment option for children with yolk sac tumors that have not responded to standard chemotherapy.
What could go wrong
This is a small, early-phase study with only 32 participants. The results may not apply to all patients, and the combination may cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

32 people

The number who actually took part.

Started

Jun 2020

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria： * The pediatric patient is required to present histological confirmation of an extracranial yolk sac tumor. * At the time of enrollment, the patient must be 18 years of age or younger, with no restrictions based on gender * The patient must exhibit disease progression following a minimum of two platinum-based chemotherapy regimens or experience a relapse after the completion of treatment * The patient must have measurable lesions, documented in accordance with the RECIST criteria, or possess an unassessable disease with alpha-fetoprotein (AFP) levels exceeding five times the upper limit of normal * The Lansky performance status score must be 50 or higher, and the patient's life expectancy should be greater than 12 weeks * The patient must have fully recovered from any prior adverse effects related to anti-cancer treatments Exclusion Criteria： * a history of previous tumors * organ failure, specifically involving the heart, brain, liver, or kidneys.

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Conditions

The condition(s) this trial relates to.

Endodermal Sinus Tumor germ cell tumor Neoplasms, Germ Cell and Embryonal yolk sac tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Germ cell tumor Yolk sac tumor

Contacts and locations

Locations

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117, China

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