Could a Pre-Surgery drug slash recurrence in rare joint tumors?

NCT ID NCT07707882

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial investigates whether taking pimicotinib—a drug that blocks a protein driving tumor growth—for 12 weeks before surgery can improve outcomes for people with diffuse tenosynovial giant cell tumor (D-TGCT), a rare but aggressive joint tumor with a high recurrence rate. Participants are randomly assigned to receive either pimicotinib followed by surgery or surgery alone. The study measures how long patients stay free of events like recurrence or progression, aiming to see if the drug-surgery combo reduces the need for repeat operations.

What this could mean

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

Active substance
pimicotinib, a CSF1R inhibitor taken orally, followed by tumor removal surgery
What this could lead to
If successful, this approach could lower the high recurrence rate of diffuse TGCT and reduce the need for repeat surgeries.
What could go wrong
This is a phase 2 trial with only 84 participants, so results may not apply broadly. Pimicotinib can cause side effects like itching, swelling, and fatigue.

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

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2027

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

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

18 years and older

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: * Male or female subjects aged ≥18 years * Histologically confirmed tenosynovial giant cell tumor (TGCT) * Resectable diffuse tenosynovial giant cell tumor (D-TGCT) were determined by multidisciplinary team (MDT) discussion. * Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 with at least one lesion of ≥2 cm * Symptomatic disease with a worst pain of at least 4 or/and a worst stiffness of at least 4 (based on a scale of 0-10 with 10 describing the worst condition) prior to randomization Adequate organ and bone marrow function * Adequate organ function and bone marrow function * Willing and able to complete patient-reported outcome (PRO) assessments throughout the study. Exclusion Criteria: * Prior treatment with highly selective Colony-Stimulating Factor 1 (CSF1)/ Colony-Stimulating Factor 1 Receptor (CSF1R) inhibitors before randomization * Presence of another malignancy requiring active treatment, in the investigator's judgment, which may interfere with study participation or results * Known metastatic TGCT * Severe concomitant arthropathy, severe illness, or uncontrolled infection in the affected joint * Significant factors affecting oral drug absorption * Concomitant use of strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days before randomization * Impaired cardiac function or severe cardiac disease * Known active Human Immunodeficiency Virus (HIV) infection, active hepatitis B, active hepatitis C, or active tuberculosis before randomization * Known active liver or biliary disease, or other conditions that may cause abnormal liver function tests during the study * Pregnant or lactating female (pregnancy defined as from conception until termination) * Fertile males or non-sterilized females who do not agree to use effective contraception from at least 14 days before randomization until 6 months after the last dose of study drug * Other serious comorbidities that, in the investigator's judgment, may affect protocol compliance, interfere with interpretation of study results, or increase the patient's risk of safety events

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Orthopedics, The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China

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