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NCT04072042RecruitingPhase 2

BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma

A Biomarker Driven, Open Label, Phase II Study of VEGFR2 Inhibitor Apatinib in Patients With Recurrent or Refractory Advanced Bone and Soft Tissue Sarcoma

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
25 Aug 2019
Start date
30 Oct 2019
Primary completion date
30 Oct 2026
Lead sponsor
Ruijin Hospital
NCT number
NCT04072042

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 30 Oct 2019 to the primary completion date, 30 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 8 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.