癌研連線CancerLink
进行中（不再招募） NCT05059262

Vimseltinib 用于腱鞘巨细胞瘤的研究

胆道癌Phase IIIIII 期IV 期

这是一项多中心第三期临床研究，旨在评估一种名为 vimseltinib 的研究性药物用于治疗腱鞘巨细胞瘤（TGCT）的疗效，适用于无法进行手术切除肿瘤的情况。 该研究分为两部分。在第一部分中，符合条件的研究参与者将被分配接受 vimseltinib 或匹配的安慰剂治疗 24 周。

适应症：Tenosynovial Giant Cell Tumor、Pigmented Villonodular Synovitis、Giant Cell Tumor of Tendon Sheath、Tenosynovial Giant Cell Tumor, Diffuse、Tenosynovial Giant Cell Tumor, Localized

入组条件

纳入标准

  • Patients ≥18 years of age
  • TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
  • Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record
  • Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
  • Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
  • Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm
  • Adequate organ and bone marrow function
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
  • Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
  • Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device

排除标准

  • Previous use of systemic therapy (investigational or approved) targeting colony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed
  • Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
  • Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
  • QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome
  • Concurrent treatment with any study-prohibited medications
  • Major surgery within 14 days of the first dose of study drug
  • Any clinically significant comorbidities
  • Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis
  • Malabsorption syndrome or other illness that could affect oral absorption
  • Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection
  • If female, the participant is pregnant or breastfeeding
  • Known allergy or hypersensitivity to any component of the study drug
  • Contraindication to MRI

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。