BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma

Sponsor
Ruijin Hospital
Study ID
NCT04072042
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
8 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of this study is to evaluate the efficacy and safety of Apatinib monotherapy for relapsed or refractory advanced bone and soft tissue sarcoma with VEGFR-2 (KDR) 604A\>G polymorphism as predictive biomarker

Key Dates

Start date
Oct 30, 2019
Status verified
May 2025
Primary completion
Oct 30, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VEGFR SNP-Positive Sarcoma Arm (VEGFR-AtoG)
    In this arm, patients with VEGFR2-604 A\>G single nucleotide polymorphism (SNP) were recruited for the efficacy analysis. Biomarker positive patients will receive Apatinib 250mg tablet by mouth, bid. Biomarker negative patients are treated with the same regimens as a non-comparative, non-randomized, pragmatic control without a pre-specified sample size.
  • Experimental: CSF1-Positive Sarcoma Arm (CSF1-high)
    In this arm, patients with CSF1-positivity were recruited for the efficacy analysis. CSF1-positivity is defined as CSF1 copy number amplification and/or CSF1 expression ≥ 30% by immunohistochemistry (IHC) in the sarcoma tumor specimen according to the institutional pathological review. Biomarker positive patients will receive Apatinib 250mg tablet by mouth, bid. Biomarker negative patients are treated with the same regimens as a non-comparative, non-randomized, pragmatic control without a pre-specified sample size.
  • Experimental: 4q12 amplicon-Positive Sarcoma Arm (4q12-amp)
    In this arm, patients with 4q12 amplicon (4q12-amp) were recruited for the efficacy analysis. 4q12-amp is defined as copy number amplification of chromosome segment 4q12 detected by fluorescence in situ hybridization (FISH) in the sarcoma tumor specimen according to the institutional pathological review. Biomarker positive patients will receive Apatinib 250mg tablet by mouth, bid. Biomarker negative patients are treated with the same regimens as a non-comparative, non-randomized, pragmatic control without a pre-specified sample size.

Primary Outcome Measure

4 month-progression free rate (PFR) in each of the 3 cohorts [ Time Frame: 4 months from recruitment ]

Central Contacts

Related Studies