Chinese PLA Generation Hospital
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Peritoneal adhesion ORR (pORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
- •Age of 18-70, Karnofsky score higher than
- •No severe functional damage of major organ, normal liver and kidney function.
- •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.
排除标准
- •Complete intestinal obstruction and suitable for surgery.
- •Patients known to be allergic to bevacizumab or any of the components of the drug.
- •Other ongoing anti-tumor treatment.
- •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
- •Active wound infection and a history of uncontrolled psychiatric illness.
研究组 & 干预措施
Intraperitoneal bevacizumab+ carboplatin
Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
干预措施: Bevacizumab (Drug)
Intraperitoneal bevacizumab+ carboplatin
Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
干预措施: Carboplatin (Drug)
Intraperitoneal bevacizumab+ carboplatin
Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
干预措施: paclitaxel (Drug)
Intraperitoneal carboplatin
Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
干预措施: Carboplatin (Drug)
Intraperitoneal carboplatin
Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
干预措施: paclitaxel (Drug)
结局指标
主要结局
Peritoneal adhesion ORR (pORR)
时间窗: 3weeks after the last treatment
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.
次要结局
- Quality of Life (QoL)(From first dose up to 1 year)
- Progression free survival (PFS)(Up to 3 years)
- Overall survival (OS)(Up to 3 years)
- Number of Patients with Adverse Events(From first dose up to 1 month after the last treatment)
- Objective Response Rate (ORR)(Up to 1 year)
研究者
DuNan
Director of oncology
Chinese PLA General Hospital