Malignant Ascites, Malignant Pleural Effusion
Conditions
Brief summary
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.
Interventions
DRUGEndostar
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
DRUGCisplatin
cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of thoracic or abdominal tumor * At least medium amount of malignant pleural effusion or ascites * ECOG Performance Status 0-2 * Life expectancy ≥ 2 months * Adequate hematologic, cardiac, renal, and hepatic function * No major surgery within 4 weeks prior to this study * Written informed consent
Exclusion criteria
* Patients with central nervous system (CNS) metastases * Evidence of bleeding diathesis, serious infection * Evidence of myocardial infarction, unstable angina or cardiac insufficiency * Presence of serious COPD and/or respiratory failure * Allergic to study drug * Pregnant or lactating women * Participation in other clinical trials within 30 days prior to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | baseline to measured progressive disease, every three weeks | WHO criteria |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression | baseline to every three weeks until disease progression |
| Quality of Life | baseline to every three weeks |
| Incidence of Adverse Events | Up to 1 month after the last treatment |
Countries
China
Outcome results
None listed