Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Gia… (NCT07707882) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Giant Cell Tumor
China84 participantsStarted 2027-10-01
Plain-language summary
Tenosynovial giant cell tumor (TGCT) is a rare neoplasm predominantly occurring in young and middle-aged adults, characterized by high recurrence and high disability rates. Surgery represents the first-line treatment at present. Although surgical resection can eradicate lesions, repeated surgical interventions constitute the major disease-related burden. Particularly for patients with diffuse-type TGCT (D-TGCT), postoperative recurrence rates can exceed 50%.
Pimicotinib is a highly selective colony-stimulating factor 1 receptor (CSF1R) inhibitor. The phase III MANEUVER trial has verified its prominent tumor shrinkage effect and symptomatic improvement in patients with unresectable, symptomatic TGCT, with an objective response rate (ORR) of 54%. In addition, pimicotinib demonstrates a favorable safety profile; most adverse events are mild in severity, mainly including pruritus, edema, fatigue and elevated creatine kinase, without severe hepatotoxicity.
Neoadjuvant therapy followed by surgery falls within the scope of multimodal treatment, which is mostly applied to recurrent and refractory cases rather than the standard upfront regimen for treatment-naive patients. Clinical case reports and real-world observations have preliminarily validated the feasibility and clinical value of sequential systemic targeted therapy followed by surgical resection. To date, systematic and standardized clinical data regarding neoadjuvant strategies remain scarce, especially randomized controlled evidence comparing neoadjuvant targeted therapy plus surgery versus primary upfront surgery. This study aims to compare the efficacy and safety of neoadjuvant pimicotinib combined with surgery versus upfront primary surgery in the management of D-TGCT, so as to generate evidence-based rationale for developing more effective and safe therapeutic regimens for D-TGCT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Event-free survival
Timeframe: 2 years
Trial details
NCT IDNCT07707882
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine