Apatinib Combined With Chemotherapy in the Treatment of Soft Tissue Sarcoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04126811
Phase
PHASE2
Status
Unknown

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate, Pirarubicin, Ifosfamide — DRUG
    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.
  • Apatinib Mesylate — DRUG
    Apatinib 500mg, orally, once a day. One cycle every 4 weeks.
  • Pirarubicin, Ifosfamide — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 1, 2019
Status verified
Sep 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib and Chemotherapy Test Group
    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.
  • Active Comparator: Apatinib Group
    Apatinib 500mg, orally, once a day. One cycle every 4 weeks.
  • Active Comparator: Chemotherapy Group
    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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Within 2 years ]

Central Contacts

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