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Old drug, new hope: thalidomide combo shows promise for kids with rare cancer

NCT ID NCT06470464

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed phase 2 trial tested a combination of thalidomide and three chemotherapy drugs (nab-paclitaxel, gemcitabine, epirubicin) in 20 children with relapsed or refractory yolk sac tumor, a rare germ cell cancer. The goal was to see if this new mix could shrink tumors or lower tumor markers. The study is the first to report this specific combination for children whose cancer returned after standard treatments.

What this could mean

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

Active substance
thalidomide combined with nab-paclitaxel, gemcitabine, and epirubicin
What this could lead to
If it works, this 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 trial with only 20 participants, so results may not apply to all patients. Thalidomide can cause side effects like nerve damage and blood clots.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 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: 1. The child must have histological evidence of an extracranial malignant germ cell tumor (vitelline sac tumor). 2. Children must be no more than 18 years old at the time of study participation. 3. The patients were children with vitelline cystic tumor who were resistant to drugs after at least two platinum-containing chemotherapy regimes or whose disease recurred within 3 months after chemotherapy regimes, or who recurred again or repeatedly after treatment with Sirolimus combined with TIC chemotherapy regimes. 4. The child must have measurable lesions (recorded according to RECIST criteria) or non-evaluable disease with tumor marker AFP greater than 5 times the upper limit of normal. 5. Lansky performance status score ≥50. 6. The life expectancy of the child must exceed 6 weeks. 7. The child must have recovered from the response to all previous anticancer treatments. 8. No serious organ dysfunction: normal cardiac function (ejection fraction \> 50% or BNP \< 2000pg/ml); Liver function: alanine aminotransferase increased less than 5 times the upper limit of normal, bilirubin increased less than 3 times the upper limit of normal; Renal function: creatinine and urea nitrogen levels below the normal range; The white blood cells were greater than 3×109/L, and the platelets were greater than 100×109/L. 9. Obtain the informed consent of the guardian and sign the informed consent. Exclusion Criteria: 1. Patients with other tumors. 2. Heart, brain, liver, kidney and other organ failure patients.

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Conditions

The condition(s) this trial relates to.

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