Tenosynovial Giant Cell Tumor, DiffusePhase 2NEXPERTNCT07707882
Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Giant Cell Tumor
A Phase 2 study testing Pimicotinib and Tumor resection surgery in people with Tenosynovial Giant Cell Tumor, Diffuse, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tenosynovial Giant Cell Tumor, Diffuse
- What is being tested?
- Pimicotinib and Tumor resection surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2027to 30 Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Orthopedics, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zhaoming Ye, +86-0571-87783777, yezhaoming@zju.edu.cn
About this study
Official title: Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Giant Cell Tumor: A Randomized, Open-label Trial
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.
- Conditions
- Tenosynovial Giant Cell Tumor, Diffuse
- Being tested
- Pimicotinib, Tumor resection surgery
- Medical subject headings
- Synovitis, Pigmented Villonodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimicotinibDrug
Pimicotinib 50 mg orally once daily for 12 consecutive weeks.
Tumor resection surgeryProcedure or surgery
Open surgery will be performed based on patient and tumor characteristics discussed at the multidisciplinary team (MDT) meeting. The specific surgical plan will be determined by the surgeon based on clinical judgment. Surgical procedures will follow national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Therapy plus Surgery | Experimental | Patients take neoadjuvant pimicotinib first, then undergo subsequent surgical resection of the lesion. Receives: Drug: Pimicotinib; Procedure: Tumor resection surgery |
| Upfront Surgery | Active comparator | Patients undergo surgical tumor resection right after study enrollment. Receives: Procedure: Tumor resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Events are defined as disease progression precluding planned surgery, local recurrence, distant metastasis, treatment discontinuation due to adverse events, or death from any cause.
Measured: 2 years
Secondary outcomes (6)
Local recurrence rate
Measured: 2 year
Surgical complication rate
Measured: 2 years
Change in range of motion
Measured: 2 years
Change in Brief Pain Inventory (BPI)
Score range: 0-10; Higher scores mean more severe pain and greater life interference; lower scores mean pain relief.
Measured: 2 years
Change in stiffness Numerical Rating Scale (NRS)
Score range: 0-10; Higher score means worse joint stiffness; reduced score indicates improvement.
Measured: 2 years
Change in Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) score
This PROMIS Physical Function short form contains items with 5-point Likert response (1=unable to do, 5=no difficulty at all).The raw score from these responses is then converted to a standardized T-score on a scale of 0 to 100, with a mean of 50 and a standard deviation of 10. The total score is the final T-score. Higher T-score indicates better physical function.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Oct 2027 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tenosynovial Giant Cell Tumor, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707882
- Sponsor's protocol ID
- 2026-0643
- Acronym
- NEXPERT
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu H, Niu X, Ravi V, Martin-Broto J, Razak AA, Saleh R, Zhou Y, Shen J, Liu T, Sankhala KK, Serrano C, Stacchiotti S, Wang J, Baldi GG, Feng Y, Hua Y, Li T, Rutkowski P, Zhang X, Tinoco G, Zou Q, Shan B, Zhu X, Gelderblom H. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Mar 14;407(10533):1072-1083. doi: 10.1016/S0140-6736(25)02602-9. Epub 2026 Mar 5.
PubMed 41796601van de Sande M, Blay JY, Tap W, Lee M, Kaiser E, Beaver S, Harrow B, Zeringo NA, Bernthal N. The economic and humanistic burden of tenosynovial giant cell tumor: a targeted literature review. Future Oncol. 2025 Aug;21(18):2385-2400. doi: 10.1080/14796694.2025.2520744. Epub 2025 Jun 22.
PubMed 40545745Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martin-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. doi: 10.1016/S0140-6736(19)30764-0. Epub 2019 Jun 19.
PubMed 31229240Stacchiotti S, Durr HR, Schaefer IM, Woertler K, Haas R, Trama A, Caraceni A, Bajpai J, Baldi GG, Bernthal N, Blay JY, Boye K, Broto JM, Chen WT, Dei Tos PA, Desai J, Emhofer S, Eriksson M, Gronchi A, Gelderblom H, Hardes J, Hartmann W, Healey J, Italiano A, Jones RL, Kawai A, Leithner A, Loong H, Mascard E, Morosi C, Otten N, Palmerini E, Patel SR, Reichardt P, Rubin B, Rutkowski P, Sangalli C, Schuster K, Seddon BM, Shkodra M, Staals EL, Tap W, van de Rijn M, van Langevelde K, Vanhoenacker FMM, Wagner A, Wiltink L, Stern S, Van de Sande VM, Bauer S. Best clinical management of tenosynovial giant cell tumour (TGCT): A consensus paper from the community of experts. Cancer Treat Rev. 2023 Jan;112:102491. doi: 10.1016/j.ctrv.2022.102491. Epub 2022 Dec 6.
PubMed 36502615Mosher H, Dean K, Meli G, Desrosiers J, Crawford B, Temple HT, Hornicek FJ, Rosenberg AE, Jonczak E, Palmerini E, Geiger EJ. Current Treatment Strategies for Diffuse Tenosynovial Giant Cell Tumor: A Review of the Literature. JB JS Open Access. 2026 Jan 13;11(1):e25.00313. doi: 10.2106/JBJS.OA.25.00313. eCollection 2026 Jan-Mar.
PubMed 41523664Mastboom MJL, Lips W, van Langevelde K, Mifsud M, Ng C, McCarthy CL, Athanasou NA, Gibbons CLMH, van de Sande MAJ. The effect of Imatinib Mesylate in diffuse-type Tenosynovial Giant Cell Tumours on MR imaging and PET-CT. Surg Oncol. 2020 Dec;35:261-267. doi: 10.1016/j.suronc.2020.08.030. Epub 2020 Aug 26.
PubMed 32932224Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3.
PubMed 38843860Geiger EJ, Jensen AR, Singh AS, Nelson SD, Bernthal NM. Use of neoadjuvant pexidartinib with limb salvage surgery for diffuse tenosynovial giant cell tumor: A case report. J Orthop Sci. 2024 Jan;29(1):458-462. doi: 10.1016/j.jos.2022.10.016. Epub 2022 Nov 16. No abstract available.
PubMed 36402606Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.
PubMed 33926503Bernthal NM, Randall RL, Zeitlinger LN, Geiger EJ, Healey JH. Complementary Effects of Surgery and Pexidartinib in the Management of Patients with Complex Diffuse-Tenosynovial Giant Cell Tumor. Case Rep Orthop. 2022 Dec 3;2022:7768764. doi: 10.1155/2022/7768764. eCollection 2022.
PubMed 36510622
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Giant Cell Tumor: A Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT07707882
- Acronym / sponsor ID
- NEXPERT / 2026-0643
- Conditions
- Tenosynovial Giant Cell Tumor, Diffuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Therapy plus Surgery | Experimental | Drug: Pimicotinib, Procedure: Tumor resection surgeryPatients take neoadjuvant pimicotinib first, then undergo subsequent surgical resection of the lesion. |
| Upfront Surgery | Active comparator | Procedure: Tumor resection surgeryPatients undergo surgical tumor resection right after study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimicotinibPimicotinib 50 mg orally once daily for 12 consecutive weeks. | Drug | Neoadjuvant Therapy plus Surgery |
| Tumor resection surgeryOpen surgery will be performed based on patient and tumor characteristics discussed at the multidisciplinary team (MDT) meeting. The specific surgical plan will be determined by the surgeon based on clinical judgment. Surgical procedures will follow national guidelines. | Procedure or surgery | Neoadjuvant Therapy plus Surgery, Upfront Surgery |
Primary outcome
Event-free survival
Time frame: 2 years
Events are defined as disease progression precluding planned surgery, local recurrence, distant metastasis, treatment discontinuation due to adverse events, or death from any cause.
6 secondary outcomes
Local recurrence rate
Time frame: 2 year
Surgical complication rate
Time frame: 2 years
Change in range of motion
Time frame: 2 years
Change in Brief Pain Inventory (BPI)
Time frame: 2 years
Change in stiffness Numerical Rating Scale (NRS)
Time frame: 2 years
Change in Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) score
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 41796601Xu H, Niu X, Ravi V, Martin-Broto J, Razak AA, Saleh R, Zhou Y, Shen J, Liu T, Sankhala KK, Serrano C, Stacchiotti S, Wang J, Baldi GG, Feng Y, Hua Y, Li T, Rutkowski P, Zhang X, Tinoco G, Zou Q, Shan B, Zhu X, Gelderblom H. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Mar 14;407(10533):1072-1083. doi: 10.1016/S0140-6736(25)02602-9. Epub 2026 Mar 5.
- Background: PubMed 40545745van de Sande M, Blay JY, Tap W, Lee M, Kaiser E, Beaver S, Harrow B, Zeringo NA, Bernthal N. The economic and humanistic burden of tenosynovial giant cell tumor: a targeted literature review. Future Oncol. 2025 Aug;21(18):2385-2400. doi: 10.1080/14796694.2025.2520744. Epub 2025 Jun 22.
- Background: PubMed 31229240Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martin-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. doi: 10.1016/S0140-6736(19)30764-0. Epub 2019 Jun 19.
- Background: PubMed 36502615Stacchiotti S, Durr HR, Schaefer IM, Woertler K, Haas R, Trama A, Caraceni A, Bajpai J, Baldi GG, Bernthal N, Blay JY, Boye K, Broto JM, Chen WT, Dei Tos PA, Desai J, Emhofer S, Eriksson M, Gronchi A, Gelderblom H, Hardes J, Hartmann W, Healey J, Italiano A, Jones RL, Kawai A, Leithner A, Loong H, Mascard E, Morosi C, Otten N, Palmerini E, Patel SR, Reichardt P, Rubin B, Rutkowski P, Sangalli C, Schuster K, Seddon BM, Shkodra M, Staals EL, Tap W, van de Rijn M, van Langevelde K, Vanhoenacker FMM, Wagner A, Wiltink L, Stern S, Van de Sande VM, Bauer S. Best clinical management of tenosynovial giant cell tumour (TGCT): A consensus paper from the community of experts. Cancer Treat Rev. 2023 Jan;112:102491. doi: 10.1016/j.ctrv.2022.102491. Epub 2022 Dec 6.
- Background: PubMed 41523664Mosher H, Dean K, Meli G, Desrosiers J, Crawford B, Temple HT, Hornicek FJ, Rosenberg AE, Jonczak E, Palmerini E, Geiger EJ. Current Treatment Strategies for Diffuse Tenosynovial Giant Cell Tumor: A Review of the Literature. JB JS Open Access. 2026 Jan 13;11(1):e25.00313. doi: 10.2106/JBJS.OA.25.00313. eCollection 2026 Jan-Mar.
- Background: PubMed 32932224Mastboom MJL, Lips W, van Langevelde K, Mifsud M, Ng C, McCarthy CL, Athanasou NA, Gibbons CLMH, van de Sande MAJ. The effect of Imatinib Mesylate in diffuse-type Tenosynovial Giant Cell Tumours on MR imaging and PET-CT. Surg Oncol. 2020 Dec;35:261-267. doi: 10.1016/j.suronc.2020.08.030. Epub 2020 Aug 26.
- Background: PubMed 38843860Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3.
- Background: PubMed 36402606Geiger EJ, Jensen AR, Singh AS, Nelson SD, Bernthal NM. Use of neoadjuvant pexidartinib with limb salvage surgery for diffuse tenosynovial giant cell tumor: A case report. J Orthop Sci. 2024 Jan;29(1):458-462. doi: 10.1016/j.jos.2022.10.016. Epub 2022 Nov 16. No abstract available.
- Background: PubMed 33926503Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.
- Background: PubMed 36510622Bernthal NM, Randall RL, Zeitlinger LN, Geiger EJ, Healey JH. Complementary Effects of Surgery and Pexidartinib in the Management of Patients with Complex Diffuse-Tenosynovial Giant Cell Tumor. Case Rep Orthop. 2022 Dec 3;2022:7768764. doi: 10.1155/2022/7768764. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimicotinib and Tumor resection surgery in people with Tenosynovial Giant Cell Tumor, Diffuse, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoming Ye, MD (+86-0571-87783777, yezhaoming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707882, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.