Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Provincial People's Hospital
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Capecitabine; Endostatins; Oxaliplatin

Criteria

Inclusion Criteria:

• Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.

• There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.

• Male or female , age 18～75

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• The patients had to have a life expectancy of at least 3 months.

• A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.

• Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l.

• Informed consent was obtained from all patients.

Exclusion Criteria:

• Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.

• a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.

• patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.