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Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.

Phase 1
18 Years
70 Years
Open (Enrolling)
Refractory Malignant Ascites

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Trial Information

Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.

Inclusion Criteria:

1. Signed informed consent form;

2. Histologically or cytologically confirmed non-squamous cell carcinoma,including
colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, bile duct
cancer, ovarian cancer, peritoneal primary tumor;Ascites were diagnosed by ultrasound
or CT and confirmed malignant ascites by cytology;

3. failed to standard systemic therapy and / or no appropriate treatment for the
treatment for malignant ascites

4. Age 18-70 years;

5. Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;

6. Life expectancy of at least 8 weeks;

Exclusion Criteria:

1. systematic anti-cancer therapy, including chemotherapy (intraperitoneal
chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy
performed within 2 weeks;

2. tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial
growth factor (VEGF) performed within 4 weeks;

3. Laboratory tests:Absolute neutrophil count<1.0x109/L,Platelet count<75x
109/L,Hemoglobin<8g/dl,PT-INR≥1.5 times upper limit of normal (ULN);Bilirubin≥2 x
ULN,AST and ALT≥2.5 times ULN(no liver metastasis),≥5 times ULN(with liver
metastasis)Creatinine≥1.5 times ULN or calculated creatinine clearance, using the
Cockcroft-Gault formula,<40 mL/min;

4. uncontrolled hypertension:systolic pressure ≥160 mmHg,or diastolic pressure≥100mmHg

5. Known history of severe heart disease,uncontrolled or symptomatic angina, congestive
heart failure,clinically significant arrhythmias,myocardial infarction within six

6. active (severe or uncontrolled) bleeding (hemorrhage within 3 months> 30 ml),
hemoptysis (fresh blood, 4 weeks> 5 ml), bloody ascites

7. thrombosis, tumor thrombus events (including arterial/venous thrombosis, tumor
thrombosis, pulmonary embolism, transient ischemic attack)within 12 months;

8. Portal hypertensive disease or severe liver disease, including various types of
cirrhosis, obstructive jaundice;

9. concurrent gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative
colitis and other gastrointestinal diseases according to investigators' determination
that may cause gastrointestinal bleeding or perforation;

10. concurrent severe respiratory disease, or chronic therapy with oxygen or
corticosteroids, such as chronic obstructive pulmonary disease, interstitial lung
disease, etc.

11. Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities
greater than grade 2 or not recovered from surgery;

12. Symptomatic brain metastasis;

13. Uncontrolled systemic disease,such as infection,unstable diabetes mellitus,etc;

14. Active infection of HIV、HBV、HCV;

15. Major surgery within 4 weeks of start of study treatment, without complete recovery.

16. Pregnant or lactating women.Negative serum pregnancy test (For women of childbearing
potential);Fertile patients must use effective contraception.

17. Dementia, altered mental status, or any psychiatric condition that would prevent the
understanding or rendering of ICF;

18. Received any investigational drug treatment within 4 weeks of start of study

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse events

Outcome Description:

participants will be followed for the duration of hospital stay, an expected average of 1 week

Outcome Time Frame:

during the treatment in the hospital,an expected average of 1 week

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

June 2015

Related Keywords:

  • Refractory Malignant Ascites
  • refractory malignant ascites
  • Bevacizumab
  • intraperitoneal
  • phase I
  • Ascites