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New treatment option for Sarcoma
Official title BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma
ClinicalTrials.gov ID: NCT04072042
What this study is testing
What is Apatinib monotherapy?
Apatinib monotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sarcoma.
Also referred to as VEGFR inhibitor; Rivoceranib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 65
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility criteria
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.