Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy

Sponsor
Ruijin Hospital
Study ID
NCT03742193
Phase
PHASE2
Status
Unknown

Conditions

  • Apatinib
  • Osteosarcoma
  • Pulmonary Metastases

Eligibility Criteria

Sex
ALL
Age
10 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib 250mg tablet by mouth, bid. 48 hrs break before and 96 hrs after the surgical resection of the pulmonary metastases.
  • GD regimen — DRUG
    One cycle: gemcitabine 900 mg/m\^2 over 90 min on Day 1, and gemcitabine 900 mg/m\^2 and docetaxel 75 mg/m\^2 on Day 8. Every 21 days were eligible. 1\~2 -week break before and 2-week break after the surgical resection of the pulmonary metastases is taken.

Study Details

The aim of this study is to evaluate the efficacy and safety of Second-line chemotherapy combined with Apatinib for the patients with resectable pulmonary metastasis of osteosarcoma.

Key Dates

Start date
Aug 11, 2019
Status verified
Oct 2023
Primary completion
Nov 15, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib + GD group
    Apatinib + GD regimen. For unilateral metastases,3 cycles before metastasectomy, and 4 cycles after. For bilateral metastases, 3 cycles before first metastasectomy, 1 cycle inbetween, and then second metastasectomy followed by 4 cycles. Apatinib monotherapy is then maintained until 1 year following complete resection.

Primary Outcome Measure

12 months Progression-free survival rate(12mPFR) [ Time Frame: 12 months from the recruitment of the study ]

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