NCT03951571

Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma

Efficacy and Safety of Anlotinib Hydrochloride (AL3818) in Postoperative Adjuvant Therapy for High-grade Soft Tissue Sarcoma -- A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Anlotinib Hydrochloride Capsule combined with Best Supportive Therapy in the adjuvant treatment of patients with high-grade soft tissue sarcoma after operation, as compared with placebo combined with Best Supportive Therapy.

Conditions

• Soft Tissue Sarcoma Adult
• High Grade Sarcoma

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride	Before breakfast, take an Anlotinib hydrochloride placebo once a day, 12 mg (1 pill) at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.
DRUG	Placebo Oral Tablet	Before breakfast, take an placebo once a day, 1 pill at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.

Timeline

• Start date: 2019-05-13
• Primary completion: 2022-06-01
• Completion: 2022-12-31
• First posted: 2019-05-15
• Last updated: 2025-05-14

Locations

5 sites across 1 country: China