Using Apatinib to treat advanced or metastatic sarcoma with a specific genetic marker

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Apatinib monotherapy in patients with relapsed or refractory advanced bone and soft tissue sarcoma who have a specific VEGFR-2 genetic polymorphism. The trial aims to address the challenge of pulmonary metastases that occur after standard treatments, which affect a significant percentage of patients. By focusing on a predictive biomarker, the study seeks to improve treatment outcomes and minimize adverse effects associated with the therapy. Participants will be monitored for both the effectiveness of the drug and the incidence of complications such as pneumothorax.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Weibin Zhang — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Weibin Zhang, PhD, MD
• Email: zhangweibin10368@163.com
• Phone: +8613501824630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.