NCT04126811

Apatinib Combined With Chemotherapy in the Treatment of Soft Tissue Sarcoma

Single-center, Open, Non-randomized, Phase II Prospective Study of Apatinib Combined With Chemotherapy in the Treatment of Unresectable Soft Tissue Sarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy of apatinib combined with AI regimen chemotherapy compared with AI regimen chemotherapy and single-agent apatinib in patients with unresectable soft tissue sarcoma. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rates (ORR, CR+PR), disease control rate (DCR, CR+PR+SD), and overall survival ( OS). To observe the safety of apatinib combined with AI chemotherapy.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate, Pirarubicin, Ifosfamide	Apatinib 500mg, orally, once a day. One cycle every 4 weeks. Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.
DRUG	Apatinib Mesylate	Apatinib 500mg, orally, once a day. One cycle every 4 weeks.
DRUG	Pirarubicin, Ifosfamide	Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2019-10-15
• Last updated: 2019-10-15

Locations

1 site across 1 country: China