NCT07770074尚未招募不适用
Real-World Evidence of Second-line Systematic Therapy With BRAF V600E Mutation-guided Dabrafenib + Trametinib or Mutation-agnostic Multi-targeted Tyrosine Kinase Inhibitors (MKIs) in Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Proportion of Patients Receiving Second-line Systematic Therapy
研究概览
简要总结
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R DTC. This is a non-interventional study using secondary data derived from a real-world Electronic Health Record (rEHR) database in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of thyroid cancer.
- •Patients with a pathological confirmation of differentiated thyroid cancer (DTC).
- •Patients who initiated either MKI monotherapy (lenvatinib, sorafenib, anlotinib, donafenib, apatinib, sunitinib, cabozantinib, pralsetinib) or D+T combination therapy between January 1, 2019 and December 31, 2025 (or the data cutoff date).
- •Patients with no curative-intent thyroid cancer surgery within 3 months after initiation of systematic therapy.
排除标准
- •Patients participating in a blinded interventional clinical trial, or any open-label observational study involving D+T or MKI, during the study period.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Proportion of Patients Receiving Second-line Systematic Therapy
时间窗: Up to 6 years
Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Duration of Second-line Systematic Therapy
时间窗: Up to 6 years
Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
次要结局
- Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy(Baseline)
- Proportion of Patients by Demographics and Clinical Characteristics(Baseline)
- Age(Baseline)
- Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy(Baseline)
- Proportion of Patients by First-line Therapy(Baseline)
- Duration Between First Diagnosis of DTC and Treatment Initiation(Baseline)
- Proportion of Patients by Timing and Method of BRAF Testing(Baseline, up to 6 years)
研究者
相似试验
招募中
不适用
A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.NCT07263178Boryung Pharmaceutical Co., Ltd1,000
尚未招募
2 期
Double-T - Improving Outcomes in High-risk 2nd Line Relapsed/Refractory Large B-Cell Lymphoma Patients Eligible for CAR-T-cell Therapy With a Glofitamab-based Induction and Consolidation ConceptRelapsed /Refractory DLBCLNCT07542678Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest20
已完成
不适用
A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United StatesIGA NephropathyNCT07757048Novartis Pharmaceuticals6,286
招募中
不适用
PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric CancerNCT07607119Samsung Medical Center53
招募中
不适用
Clinical Outcomes of 3D Printed and Milled Complete DenturesNCT07586774Dentsply Sirona Implants and Consumables68