Clinical trial · Interventional
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
NCT04072042CI-TRIAL-00089648BIOVASrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- VEGFR SNP-Positive Sarcoma Arm (VEGFR-AtoG)
- description
- In this arm, patients with VEGFR2-604 A\>G single nucleotide polymorphism (SNP) were recruited for the efficacy analysis. Biomarker positive patients will receive Apatinib 250mg tablet by mouth, bid. Biomarker negative patients are treated with the same regimens as a non-comparative, non-randomized, pragmatic control without a pre-specified sample size.
- interventionNames
- Drug: Apatinib monotherapy
- type
- EXPERIMENTAL
- label
- CSF1-Positive Sarcoma Arm (CSF1-high)
- description
- In this arm, patients with CSF1-positivity were recruited for the efficacy analysis. CSF1-positivity is defined as CSF1 copy number amplification and/or CSF1 expression ≥ 30% by immunohistochemistry (IHC) in the sarcoma tumor specimen according to the institutional pathological review. Biomarker positive patients will receive Apatinib 250mg tablet by mouth, bid. Biomarker negative patients are treated with the same regimens as a non-comparative, non-randomized, pragmatic control without a pre-specified sample size.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.