BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced Sarcoma

• Status: Recruiting
• Trial end date: 2022-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. age between 8 and 65 years;

2. diagnosis of histologically confirmed advanced bone and soft tissue sarcoma excluding adipocytic tumor;

3. identification of pulmonary lesion is mandatory;

4. refractory to prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy;

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

6. adequate renal, hepatic, and hemopoietic function;normal or controlled blood pressure;

7. advanced stage that complete surgical resection of all lesions are infeasible;

8. no serious thoracic comorbidities with adequate pulmonary function for daily living;

9. 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 Criteria:

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

2. cardiac insufficiency or arrhythmia;

3. uncontrolled complications, such as diabetes mellitus and so on;

4. coagulation disorders or Hemorrhagic diseases ;

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

6. combined with other infections or wound complications;

7. wound dystrophy, poor soft-tissue around implantation risky of non-healing given angiogenesis inhibitor at baseline;

8. previously treated with VEGFR TKIs for more than 8 weeks

9. previous treated with VEGFR TKIs but off treatment due to oncological assessment or dose-limiting complications given adequate interventions.