Apatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT03359018
Phase
PHASE2
Status
Completed

Conditions

  • Clinical Benefit Rate
  • Overall Survival
  • Progression-free Survival
  • Toxicity

Eligibility Criteria

Sex
ALL
Age
11 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Every patients will received apatinib 250mg or 500mg orally daily according to their body surface area (BSA) until disease progression or intolerance to side effects.
  • SHR-1210 — DRUG
    Every patients will received SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.

Study Details

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. We have already finished a prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a objective response rate of aproximately 45% with median progression-free survival around 5 months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in order to induce durable response in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2 comparing with pazopanib or sorafenib. SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Key Dates

Start date
Jan 1, 2018
Status verified
May 2020
Primary completion
Oct 22, 2019
Completion
Jan 30, 2020

Study Design

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

Arms

  • Experimental: apatinib plus anti-PD1 therapy arm
    Every patients will received apatinib 250mg or 500mg orally daily and SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.

Primary Outcome Measure

progression-free survival [ Time Frame: up to approximately 24months ]

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