Ovarian Cancer With Malignant Ascites Clinical Trial
| NCT number | NCT01838538 |
| Other study ID # | ML25396 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | April 19, 2013 |
| Last updated | April 19, 2013 |
| Start date | June 2011 |
To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab
| Status | Recruiting |
| Enrollment | 54 |
| Est. completion date | |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. - Histologically confirmed and documented ovarian cancer with malignant ascites. - ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2. - Life expectancy of >3 months. - No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease. Exclusion Criteria: - Known hypersensitivity to any of the study drugs or excipients. - Any current anti-cancer therapy. - No evidence of ascites. - Key organ dysfunction. - Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine). - Non-healing wound, ulcer or bone fracture. - Uncontrolled psychiatric history. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | First Hospital Affiliated to the PLA General Hospital, Beijing,China | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese PLA General Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | objective response rate | 24month |