Tests apatinib in people with advanced bone or soft tissue sarcoma
Tests the drug apatinib in people whose sarcoma returned or stopped responding.
Plain-language title generated from the registry record
Registry title: BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 65 years old?
Source: NCT04072042, who can take part
Where in China
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT04072042
- Record updated
- 14 May 2025
- Original description
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 biomarkerRead full original descriptionShow less
A Biomarker Driven, Open Label, Phase II Study of VEGFR2 Inhibitor Apatinib in Patients With Recurrent or Refractory Advanced Bone and Soft Tissue Sarcoma
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
Inclusion: age between 8 and 65 years; diagnosis of histologically confirmed advanced bone and soft tissue sarcoma excluding adipocytic tumor; identification of pulmonary lesion is mandatory; refractory to prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy; 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; advanced stage that complete surgical resection of all lesions are infeasible; no serious thoracic comorbidities with adequate pulmonary function for daily living; previously treated with tyrosine kinase inhibitors (TKIs) for less than 8 weeks but off treatment due to manageable complications such as wound complications or pneumothorax without adequate interventions. The complications is resolved and disappeared at enrollment.
Exclusion: pleural or peritoneal effusion that needs to be handled by surgical treatment; wound dystrophy, poor soft-tissue around implantation risky of non-healing given angiogenesis inhibitor at baseline; previously treated with VEGFR TKIs for more than 8 weeks; previous treated with VEGFR TKIs but off treatment due to oncological assessment or dose-limiting complications given adequate interventions; 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 ; combined with other infections or wound complications.