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

NCT03577392 | Unknown Phase 2

• 1 other identifier: SIM-ED-1512
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival

  4 years

Secondary Outcomes (2)

• local control

  4 years

• Overall survival

  4 years

Study Arms (2)

XELOX chemotherapy with recombinant human endotatin

EXPERIMENTAL

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.

Drug: oxaliplatin + capecitabine (XELOX chemotherapy); Drug: rebombniant human endostatin

XELOX chemotherapy without recombinant human endotatin

ACTIVE COMPARATOR

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.

Drug: oxaliplatin + capecitabine (XELOX chemotherapy)

Interventions

oxaliplatin + capecitabine (XELOX chemotherapy) 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.

XELOX chemotherapy with recombinant human endotatin; XELOX chemotherapy without recombinant human endotatin

rebombniant human endostatin 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 with recombinant human endotatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sichuan Provincial People Hospital

Chengdu, Sichuan, 61007, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ke Xie, MD PhD

  Sichuan Provincial People Hospital

  STUDY CHAIR

Central Study Contacts

Ke Xie, MD PhD

CONTACT

008618981838382; 840246753@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Model Details: Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 5, 2018
• Study Start: July 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)