NCT03121846

Mesylate Apatinib for Stage Ⅳ STS After Failure of Chemotherapy

Mesylate Apatinib for Stage Ⅳ Soft Tissue Sarcoma Patients After Failure of Traditional Chemotherapy: Prospective, Open-label, Single-Arm, Multi-center Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, Open-label, Single-Arm, Multi-center phase II clinical trial evaluating the efficacy and safety of Apatinib for Chemotherapy Failure Ⅳ Stage Soft Tissue Sarcoma.

Detailed description

The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year survival rate is lower than 10% reported in several large-scale studies. Although chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed to improve the response rates. Long-term using of cytotoxic drugs increased the risk of toxicity in patients. Apatinib is a small molecular inhibitor of Vascular Epithelial Growth Factor Receptor-2 (VEGFR-2). It has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in STS is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in stage IV sarcoma patients who failed in chemotherapy.

Conditions

• Soft Tissue Sarcoma, Adult, Stage II

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-11-01
• Completion: 2019-05-01
• First posted: 2017-04-20
• Last updated: 2017-05-22

Locations

1 site across 1 country: China