Peritoneal Adhesion Clinical Trial
Official title:
Chinese PLA Generation Hospital
| Verified date | April 2017 |
| Source | Chinese PLA General Hospital |
| Contact | Nan Du, PhD |
| dunan304[@]163.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | June 1, 2020 |
| Est. primary completion date | June 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian 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 or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs,abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications. 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | First Affiliated Hospital, Chinese PLA General Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese PLA General Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Expression of VEGF-A in peritoneal cavity | Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration. | Up to 1 year | |
| Primary | Peritoneal adhesion ORR (pORR) | Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR. | 3weeks after the last treatment | |
| Secondary | Number of Patients with Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From first dose up to 1 month after the last treatment | |
| Secondary | Quality of Life (QoL) | Quality of Life (QoL) assessed by FACT-O | From first dose up to 1 year | |
| Secondary | Progression free survival (PFS) | From randomization until documented progressive disease or death | Up to 3 years | |
| Secondary | Overall survival (OS) | From randomization until death | Up to 3 years | |
| Secondary | Objective Response Rate (ORR) | The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1. | Up to 1 year |