Clinical trial · Interventional
Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy
A Phase II Study of Gemcitabine-docetaxel Chemotherapy With Anti-angiogenic Therapy for Pulmonary Resectable Metastases of Osteosarcoma
NCT03742193CI-TRIAL-00070980PROACHunknownPhase 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 Second-line chemotherapy combined with Apatinib for the patients with resectable pulmonary metastasis of osteosarcoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Pulmonary Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| GD regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib + GD group
- description
- Apatinib + GD regimen. For unilateral metastases,3 cycles before metastasectomy, and 4 cycles after. For bilateral metastases, 3 cycles before first metastasectomy, 1 cycle inbetween, and then second metastasectomy followed by 4 cycles. Apatinib monotherapy is then maintained until 1 year following complete resection.
- interventionNames
- Drug: Apatinib
- Drug: GD regimen
Primary outcomes (1)
- measure
- 12 months Progression-free survival rate(12mPFR)
- timeFrame
- 12 months from the recruitment of the study
- description
- The proportion of patients with progression-free survival at 12 months according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). A 12mPFR of 30% or less is considered inactive, while a 12mPFR of 50% or greater is regarded as of interest for additional development
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * age between 10 and 50 years; * diagnosis of histologically confirmed high grade osteosarcoma; * identification of pulmonary metastases without the existence of local recurrence(previous re-resection of local recurrence with wide margin is allowed). * resectable pulmonary nodule(s), defined as nodule(s) that are removable by wedge resection/ segmentectomy/lobectomy without necessitating a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels) * prior treatment consisted of standard National Comprehensive Cancer Network (NCCN) guideline recommended first-line chemotherapy * wide/radical-margin surgical resection of the primary tumor completed at least 4 weeks before enrollment. * 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; * no thoracic comorbidities with adequate pulmonary function eligible for thoracic surgery Exclusion Criteria: * previously exposed to GD chemotherapy or VEGFR2 Tyrosine-kinase inhibitors (TKIs); * existence of local recurrence; * 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 ; * metastases considered unresectable or borderline resectable at baseline * intolerable of thoracis surgery * pleural or peritoneal effusion that needs to be handled by surgical treatment; * combined with other infections or wounds * wound dystrophy, poor soft-tissue around implantation or other wound complications risky of non-healing given angiogenesis inhibitor assessed by the investigators
References
Publications (0)
Data not yet available
No reference posted for this study.