Clinical trial · Observational
Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osteosarcoma
Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osterosarcoma
NCT03358628CI-TRIAL-00030614unknownClinicalTrials.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)
By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer treatment options
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 |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Profiling & In Vivo drug testing in PDX | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Osteosarcoma
- description
- Osteosarcoma patients with metastatic relapsed or unresectable progressive disease (total n= up to 20) following resection of the primary lesion and adjuvant chemotherapy.
- interventionNames
- Other: Molecular Profiling & In Vivo drug testing in PDX
Primary outcomes (1)
- measure
- Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host
- timeFrame
- up to 2 years
- description
- Sensitivity measured by tumor growth inhibition (\>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years; 2. Diagnosis confirmed histologically and reviewed centrally; 3. Prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD); 4. Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months; 5. Adequate renal, hepatic, and hemopoietic function; 6. Normal or controlled blood pressure; 7. Surgery and/or radiotherapy completion at least 1 month before enrollment. Exclusion Criteria: 1. Central nervous system metastasis; 2. Have had other kinds of malignant tumors at the same time; 3. Cardiac insufficiency or arrhythmia; 4. Uncontrolled complications, such as diabetes mellitus and so on; 5. Coagulation disorders; 6. Urine protein≥ ++; 7. Pleural or peritoneal effusion that needs to be handled by surgical treatment; 8. Combined with other infections or wounds.
References
Publications (0)
Data not yet available
No reference posted for this study.