Pulmonary Resectable Metastases of Osteosarcoma With Apatinib and CHemotherapy

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Apatinib; Gemcitabine

Criteria

Inclusion Criteria:

• age between 10 and 50 years;

• diagnosis of histologically confirmed high grade osteosarcoma;

• identification of pulmonary metastases without the existence of local recurrence(previous re-resection of local recurrence with wide margin is allowed).

• resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels)

• prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy

• wide/radical-margin surgical resection of the primary tumor completed at least 4 weeks before enrollment.

• Eastern Cooperative Oncology Group(ECOG) performance status 0-2 with a life expectancy >3 months;

• adequate renal, hepatic, and hemopoietic function;

• normal or controlled blood pressure;

• no thoracic comorbidities with adequate pulmonary function eligible for thoracic surgery

Exclusion Criteria:

• previously exposed to GD chemotherapy or VEGFR2 Tyrosine-kinase inhibitors (TKIs);

• existence of local recurrence;

• have had other kinds of malignant tumors at the same time;

• cardiac insufficiency or arrhythmia;

• uncontrolled complications, such as diabetes mellitus and so on;

• coagulation disorders or Hemorrhagic diseases ;

• metastases considered unresectable or borderline resectable at baseline

• intolerable of thoracis surgery

• pleural or peritoneal effusion that needs to be handled by surgical treatment;

• combined with other infections or wounds

• wound dystrophy, poor soft-tissue around implantation or other wound complications risky of non-healing given angiogenesis inhibitor assessed by the investigators