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

Sichuan Provincial People's Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Quality of Life

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03577392

SIM-ED-1512

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

XELOX chemotherapy with recombinant human endotatin

Experimental group

Description:

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.

Treatment:

Drug: oxaliplatin + capecitabine (XELOX chemotherapy)

Drug: rebombniant human endostatin

XELOX chemotherapy without recombinant human endotatin

Active Comparator group

Description:

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.

Treatment:

Drug: oxaliplatin + capecitabine (XELOX chemotherapy)