Status:
RECRUITING
BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Sarcoma
Eligibility:
All Genders
8-65 years
Phase:
PHASE2
Brief 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 predict...
Detailed Description
After standard chemotherapy and surgery for the localized disease, pulmonary metastases of bone and soft tissue sarcoma occurs in up to 40% of cases and still remain challenging without satisfactory r...
Eligibility Criteria
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
- 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 ;
- pleural or peritoneal effusion that needs to be handled by surgical treatment;
- combined with other infections or wound complications;
- 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.
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04072042
Start Date
October 30 2019
End Date
September 1 2027
Last Update
May 14 2025
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025