NCT04072042 BIOmarker Driven Trial of VEGFR2 Inhibitor in Advanced or Metastatic Sarcoma
| NCT ID | NCT04072042 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-10-30 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2019-10-30 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 predictive biomarker
Eligibility 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.
Contact & Investigator
Weibin Zhang
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT04072042 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 65 Years, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04072042 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04072042 currently recruiting?
Yes, NCT04072042 is actively recruiting participants. Contact the research team at zhangweibin10368@163.com for enrollment information.
Where is the NCT04072042 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04072042 clinical trial?
NCT04072042 is sponsored by Ruijin Hospital. The principal investigator is Weibin Zhang at Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 30 participants.