Neoadjuvant anlotinib for locally advanced thyroid cancer: a single-arm phase II study (ALTER-T001)
10 affiliations
- 1Department of Thyroid and Neck Oncology, Tianjin’s Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital
- 2Department of Head and Neck Surgery, Sun Yat-sen University Cancer Center
- 3Department of Head and Neck Surgery, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China
- 4Otolaryngology & Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital, Hangzhou Medical College)
- 5Department of Thyroid & Head and Neck Surgery, Affiliated Cancer Hospital of Zhengzhou University; Henan Cancer Hospital
- 6Department of Head-Neck Surgery, Anhui Provincial Cancer Hospital
- 7Department of General Surgery, Thyroid and Parathyroid Center, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- 8Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center/Cancer Institute
- 9Department of Oncology, Shanghai Medical College, Fudan University
- 10Department of Thyroid and Breast Surgery, Tianjin Union Medical Center, The First Affiliated Hospital of Nankai University
Abstract
Background: Locally advanced thyroid cancer involving critical cervical structures is often not amenable to upfront surgery, and effective strategies are needed to improve surgical feasibility. ALTER-T001 study evaluated the safety, efficacy, and quality of life (QoL) of neoadjuvant anlotinib in this setting.
Methods: Patients with pathologically confirmed, locally advanced thyroid cancer not amenable to surgery received neoadjuvant anlotinib. “Not amenable to surgery” tumors included those unresectable, high-risk for surgery/recurrence, severely impairing QoL upon resection, or with limited adhesion to blood vessels, esophagus, or trachea. Primary endpoint was objective response rate (ORR). Secondary endpoints included time to response (TTR), disease control rate (DCR), actual operation rate, R0 resection rate, progression-free survival (PFS), QoL, and safety.
Results: In 50 DTC patients, ORR and DCR were 42.0% and 84.0% (48.8% and 97.7% in 43 evaluable cases). Median TTR was 2.8 months. Surgery occurred in 21 (42.0%) patients, yielding a 57.1% R0 rate. Median PFS in non-surgical patients was 29.8 months. The most frequent grade ≥3 treatment-related adverse event (TRAE) was hypertension (18.0%). TRAEs led to dose reductions and interruptions in 8 (16.0%) and 5 (10.0%) patients, respectively. No treatment-related deaths occurred. Global health status remained generally stable during early treatment, although deterioration in several function domains was observed. One MTC patient achieved R0 resection after 4 cycles and is presented separately as a descriptive case.
Conclusion: Neoadjuvant anlotinib exhibited acceptable efficacy, tolerability, and QoL profiles in locally advanced DTC not amenable to surgery, with potential to reduce tumor burden and facilitate conversion surgery. Larger MTC cohorts are needed to further evaluate the efficacy and safety of neoadjuvant anlotinib.
Clinical Trial Registration: https://www.chictr.org.cn/ , identifier ChiCTR2100048077.
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BibTeX
@article{li2026neoadjuvant,
title = {{Neoadjuvant anlotinib for locally advanced thyroid cancer: a single-arm phase II study (ALTER-T001)}},
author = {Dapeng Li and Ankui Yang and Zhaohui Wang and Minghua Ge and Xiangqian Zheng and Songfeng Wei and Jianwu Qin and Shengying Wang and Youben Fan and Shuwei Chen and Yibo Chen and Naisi Huang and Zhuo Tan and Bin Zhou and Shoujun Wang and Yu Wang and Ming Gao},
journal = {Frontiers in Endocrinology},
year = {2026},
month = nov,
doi = {10.3389/fendo.2026.1960030},
url = {https://www.frontiersin.org/articles/10.3389/fendo.2026.1960030/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Neoadjuvant anlotinib for locally advanced thyroid cancer: a single-arm phase II study (ALTER-T001)
AU - Dapeng Li
AU - Ankui Yang
AU - Zhaohui Wang
AU - Minghua Ge
AU - Xiangqian Zheng
AU - Songfeng Wei
AU - Jianwu Qin
AU - Shengying Wang
AU - Youben Fan
AU - Shuwei Chen
AU - Yibo Chen
AU - Naisi Huang
AU - Zhuo Tan
AU - Bin Zhou
AU - Shoujun Wang
AU - Yu Wang
AU - Ming Gao
PY - 2026
DA - 2026/11/02
JO - Frontiers in Endocrinology
DO - 10.3389/fendo.2026.1960030
UR - https://www.frontiersin.org/articles/10.3389/fendo.2026.1960030/full
AB - Background: Locally advanced thyroid cancer involving critical cervical structures is often not amenable to upfront surgery, and effective strategies are needed to improve surgical feasibility. ALTER-T001 study evaluated the safety, efficacy, and quality of life (QoL) of neoadjuvant anlotinib in this setting. Methods: Patients with pathologically confirmed, locally advanced thyroid cancer not amenable to surgery received neoadjuvant anlotinib. “Not amenable to surgery” tumors included those unresectable, high-risk for surgery/recurrence, severely impairing QoL upon resection, or with limited adhesion to blood vessels, esophagus, or trachea. Primary endpoint was objective response rate (ORR). Secondary endpoints included time to response (TTR), disease control rate (DCR), actual operation rate, R0 resection rate, progression-free survival (PFS), QoL, and safety. Results: In 50 DTC patients, ORR and DCR were 42.0% and 84.0% (48.8% and 97.7% in 43 evaluable cases). Median TTR was 2.8 months. Surgery occurred in 21 (42.0%) patients, yielding a 57.1% R0 rate. Median PFS in non-surgical patients was 29.8 months. The most frequent grade ≥3 treatment-related adverse event (TRAE) was hypertension (18.0%). TRAEs led to dose reductions and interruptions in 8 (16.0%) and 5 (10.0%) patients, respectively. No treatment-related deaths occurred. Global health status remained generally stable during early treatment, although deterioration in several function domains was observed. One MTC patient achieved R0 resection after 4 cycles and is presented separately as a descriptive case. Conclusion: Neoadjuvant anlotinib exhibited acceptable efficacy, tolerability, and QoL profiles in locally advanced DTC not amenable to surgery, with potential to reduce tumor burden and facilitate conversion surgery. Larger MTC cohorts are needed to further evaluate the efficacy and safety of neoadjuvant anlotinib. Clinical Trial Registration: https://www.chictr.org.cn/ , identifier ChiCTR2100048077.
SN - 1664-2392
ER -