NCT05602415

Anlotinib and Radiotherapy in Resectable Soft Tissue Sarcoma

A Phase II Study of Postoperative Radiotherapy With Tyrosine Kinase Inhibitor (Anlotinib) for Resectable Soft Tissue Sarcoma With High Recurrence Risk

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of dose reduced postoperative radiotherapy combined with Anlotinib for patients of soft tissue sarcoma

Detailed description

Right now, resection and radiotherapy (RT) is the most effective and recommended treatment for soft tissue sarcoma (STS). Local recurrence rate has significantly reduced since the application of RT. However, RT has brought a lot of complications which had disturbed patients' quality of life. Anlotinib is a novel tyrosine kinase inhibitor targeting multiple factors involving tumor proliferation, vasculature, and tumor microenvironment. Anlotinib inhibits VEGF/VEGFR signaling by selectively targeting VEGFR-2,-3 and FGFR-1,-2,-3,-4 with high affinity. Anlotinib also suppresses the activity of PDGFRα/β, c-Kit, Ret, Aurora-B, c-FMS, and discoidin domain receptor 1 (DDR1), leading to significant inhibition of tumor proliferation. In phase I study, anlotinib showed promising antitumor potential against STS. In a phase II study, anlotinib showed antitumor activity in several STS with well tolerant and manageable adverse effect. In this clinical study, investigators will explore the efficacy of Anlotinib combined with dose reduced postoperative radiotherapy on recurrence and metastasis control of STS. Patients with STS would receive standard treatment and recommended dose of radiotherapy. In addition, they will receive anotinib from 3 or 4 weeks after surgery, and continue for 3 months. The primary endpoint is Local Recurrence Free Survival (LRFS).

Conditions

• Soft Tissue Sarcoma
• High Risk of Recurrence
• Anlotinib
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib of 12mg will be administered orally, once daily, 2-days on/1-day off, until disease progression according to RECIST 1.1, death, unacceptable toxicity, or withdrawal of consent for any reasons. A cycle was considered to be 3 weeks. Anlotinib should be started 3-4 weeks after surgery, and continued for 3 months (4 cycles). The dose could be reduced to 8-10 mg once daily for patients who had grade 3 or 4 treatment-related toxicities, or for patients with intolerable grade 2 toxicity, despite maximum supportive care measures. If dose reduction was necessary, then the dose of anlotinib was reduced to 10 mg once daily. If further dose reduction was necessary, the dosage was reduced to 8 mg once daily. If the dosage of 8 mg once daily was not tolerable, then the patient stopped receiving anlotinib.
RADIATION	Radiotherapy	Postoperative radiotherapy would be performed. Postoperative intensity-modu¬lated RT (IMRT) will be performed (50 Gy in 2.0 Gy per fraction). No boost dose would be added if the margin was negative, a boost dose of 10-16 Gy would be added if the margin was microscopically positive, and a boost dose of 16-18 would be added if the margin was gross positive.
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-01-01
• Completion: 2024-05-01
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: China