Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion

Last updated: April 11, 2017
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03095001
Intraperitoneal bev
  • Ages 18-70
  • Female

Study Summary

Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.

Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically and radiologically confirmed stage IV or postoperative recurrenceovarian cancer.

  2. Age of 18-70, Karnofsky score higher than 80.

  3. No severe functional damage of major organ, normal liver and kidney function.

  4. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy orabdominal operations, and classification according to Nair criteria is performed. (1)must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominaldistension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesionsigns，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4)B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.

Exclusion

Exclusion Criteria:

  1. Complete intestinal obstruction and suitable for surgery.

  2. Patients known to be allergic to bevacizumab or any of the components of the drug.

  3. Other ongoing anti-tumor treatment.

  4. Heart disease with significant clinical symptoms, such as: congestive heart failure,coronary heart disease with symptom, arrhythmia hardly be controlled by drugs,myocardial infarction in 6 months, or heart failure

  5. Active wound infection and a history of uncontrolled psychiatric illness.

Study Design

Total Participants: 70
Study Start date:
June 01, 2017
Estimated Completion Date:
June 01, 2020

Connect with a study center

  • First Affiliated Hospital, Chinese PLA General Hospital

    Beijing, Beijing 100048
    China

    Active - Recruiting

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