Clinical trial · Interventional
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases
NCT01410370CI-TRIAL-00010118unknownPhase 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 clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6MV-X ray | Radiation | — | UNRESOLVED |
| Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Radiotherapy plus Endostar
- interventionNames
- Radiation: 6MV-X ray
- Drug: Endostar
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- Radiotherapy
- interventionNames
- Radiation: 6MV-X ray
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 1 month after initial treatment
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignancy with presence of intraparenchymal brain metastases * Karnofsky performance status ≥ 40 * Measurable disease according to RECIST criteria * Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L * Renal function: Cr ≤ 2.0×ULN * Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN * Adequate cardiac function * Life expectancy ≥ 3 months Exclusion Criteria: * Evidence of bleeding diathesis or serious infection * Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * Uncontrollable mental and nervous disorders * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.