Using Apatinib to treat advanced or metastatic sarcoma with a specific genetic marker
A Biomarker Driven, Open Label, Phase II Study of VEGFR2 Inhibitor Apatinib in Patients With Recurrent or Refractory Advanced Bone and Soft Tissue Sarcoma
This study is testing if the drug Apatinib can help people with advanced bone and soft tissue sarcoma who have a specific genetic marker feel better and have fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 65 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, Apatinib, Cabozantinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04072042 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 8 to 65 with advanced bone and soft tissue sarcoma who have experienced treatment failure with standard chemotherapy.
Not a fit: Patients with adipocytic tumors or those with serious thoracic comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted therapeutic option for patients with advanced sarcoma, potentially improving survival rates and quality of life.
How similar studies have performed: Previous studies have shown promising results with similar VEGFR inhibitors in treating advanced sarcoma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.