Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Tissue Adhesions

Cicatrix

Fibrosis

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles

Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks

Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles

carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles

paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles

paclitaxel

Nan Du, PhD

Hui Zhao, Phd

Nan Du, Phd

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.

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

Chinese PLA Generation Hospital

Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration.

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.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

From randomization until documented progressive disease or death

The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital

Spots Global Cancer Trial Database for peritoneal adhesion