Related Experiment Video
Updated: Sep 24, 2025
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
Apatinib in patients with recurrent or metastatic thymic epithelial tumor: a single-arm, multicenter, open-label,
Zhengbo Song1, Guangyuan Lou2, Yina Wang3
1Department of Clinical Trial, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, 310022, Zhejiang, China.
Background:
Thymic epithelial tumors (TETs) are rare malignancies and the treatment options are limited. We aimed to evaluate the efficacy and safety of apatinib, an angiogenesis inhibitor, in advanced TETs.
Methods:
This was an open-label, single-arm, phase II trial at three centers in China. Patients with TET who had progressed after failure of at least one line of platinum-based chemotherapy were enrolled. Patients received apatinib 500 mg orally per day. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.
Results:
From June 29, 2017, to April 18, 2019, 25 patients were enrolled. At data cut off (September 30, 2021), one patient achieved complete response, nine achieved partial response, and 11 achieved stable disease, with an ORR of 40% (95% CI 21-61%) and DCR of 84% (95% CI 64-95%). The median PFS was 9.0 (95% CI 5.4-12.6) months. The median OS was 24.0 (95% CI 8.2-39.8) months. All patients reported treatment-related adverse events (TRAEs). Grade 3 TRAEs occurred 26 times in 15 patients. No grade 4 or 5 toxicities occurred.
Conclusions:
This is the first trial of apatinib for the treatment of TETs. Apatinib showed promising antitumor activity and the toxicities were tolerable and manageable.
Insights
Apatinib, an angiogenesis inhibitor, demonstrated promising antitumor activity in advanced thymic epithelial tumors (TETs), with manageable side effects. This study offers new hope for patients with limited treatment options for rare TETs.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Thymic epithelial tumors (TETs) are rare cancers with limited treatment options.
- Angiogenesis inhibitors represent a potential therapeutic avenue for advanced TETs.
Purpose of the Study:
- To evaluate the efficacy and safety of apatinib in patients with advanced thymic epithelial tumors.
- To determine the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of apatinib in this patient population.
Main Methods:
- An open-label, single-arm, phase II clinical trial was conducted across three centers in China.
- Twenty-five patients with advanced TETs, who failed at least one line of platinum-based chemotherapy, were enrolled.
- Patients received oral apatinib 500 mg daily, with ORR, PFS, OS, disease control rate (DCR), and safety as endpoints.
Main Results:
- The objective response rate (ORR) was 40% (95% CI 21-61%), with one complete response and nine partial responses.
- The disease control rate (DCR) was 84% (95% CI 64-95%), with a median progression-free survival (PFS) of 9.0 months.
- Median overall survival (OS) was 24.0 months; all patients experienced treatment-related adverse events (TRAEs), with 15 experiencing Grade 3 TRAEs.
Conclusions:
- Apatinib demonstrated promising antitumor activity in advanced thymic epithelial tumors.
- The observed toxicities were generally tolerable and manageable.
- This trial provides the first evidence of apatinib's efficacy in TETs, suggesting it as a potential treatment option.
