NCT03890068

Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

Status unknown Phase 2 Last updated 1 August 2023

What this trial tests

Phase 2 trial testing Anlotinib Hydrochloride in Soft Tissue Sarcoma in 48 participants. Status unknown.

Timeline

11 April 2019

Primary endpoint
30 December 2023

30 May 2024

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	11 April 2019
Primary completion	30 December 2023
Estimated completion	30 May 2024
Sites	1 location across China

Drugs / interventions tested

• Anlotinib Hydrochloride

Conditions studied

• Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in clinical trials (ALTER-0203). Therefore, this study evaluates the safety and efficacy of anlotinib as maintenance treatment of disease control in advanced soft tissue sarcoma.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anlotinib: A Novel Targeted Drug for Bone and Soft Tissue Sarcoma.
   Li S. · · 2021 · cited 60× · PMID 34094958 · DOI 10.3389/fonc.2021.664853
2. Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial.
   Xu B, Pan Q, Pan H, Li H, et al · · 2023 · cited 28× · PMID 37767191 · DOI 10.1016/j.eclinm.2023.102240
3. The real-world clinical outcomes and treatment patterns of patients with unresectable locally advanced or metastatic soft tissue sarcoma treated with anlotinib in the post-ALTER0203 trial era.
   Zhang RS, Liu J, Deng YT, Wu X, et al · · 2022 · cited 19× · PMID 35191609 · DOI 10.1002/cam4.4613
4. Comprehensive guidance on the diagnosis and management of primary mesenchymal tumours of the thyroid gland.
   Gubbi S, Thakur S, Avadhanula S, Araque KA, et al · · 2020 · cited 9× · PMID 33152312 · DOI 10.1016/s1470-2045(20)30332-6
5. Targeting liposarcoma: unveiling molecular pathways and therapeutic opportunities.
   Liu H, Wang X, Liu L, Yan B, et al · · 2024 · cited 2× · PMID 39723387 · DOI 10.3389/fonc.2024.1484027
6. Efficacy and safety of anlotinib for the treatment of advanced bone and soft tissue sarcomas: a systematic review and meta-analysis.
   Li Z, Fang P, Shen S, Zhang L, et al · · 2025 · PMID 41395622 · DOI 10.3389/fonc.2025.1703261
7. MAPK-targeted therapies in non-gastrointestinal stromal tumor soft tissue sarcomas: current landscape and future directions.
   Al Jarroudi O, El Bairi K, Brahmi SA, Afqir S. · · 2025 · PMID 40909947 · DOI 10.3389/fonc.2025.1418537