Could a Pre-Surgery drug slash recurrence in rare joint tumors?
NCT ID NCT07707882
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2027
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Orthopedics, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
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