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

NCT ID: NCT03577392

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-08-01

Brief 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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

XELOX chemotherapy with recombinant human endotatin

Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.

Group Type: EXPERIMENTAL

oxaliplatin + capecitabine (XELOX chemotherapy)

Intervention Type: DRUG

Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.

rebombniant human endostatin

Intervention Type: DRUG

Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.

XELOX chemotherapy without recombinant human endotatin

Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.

Group Type: ACTIVE_COMPARATOR

oxaliplatin + capecitabine (XELOX chemotherapy)

Intervention Type: DRUG

Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.

Interventions

oxaliplatin + capecitabine (XELOX chemotherapy)

Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.

Intervention Type: DRUG

rebombniant human endostatin

Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ming zeng, MD

Director of Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ke Xie, MD PhD

Role: STUDY_CHAIR

Sichuan Provincial People Hospital

Locations

Sichuan Provincial People Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ke Xie, MD PhD

Role: CONTACT

840246753@qq.com

008618981838382

Facility Contacts

ke xie, MD PhD

Role: primary

Xiong jingyan

Role: backup

Other Identifiers

SIM-ED-1512

Identifier Type: -

Identifier Source: org_study_id