Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
Phase 2
- Conditions
- Quality of Life
- Interventions
- Registration Number
- NCT03577392
- Lead Sponsor
- Sichuan Provincial People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XELOX chemotherapy without recombinant human endotatin oxaliplatin + capecitabine (XELOX chemotherapy) 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. XELOX chemotherapy with recombinant human endotatin oxaliplatin + capecitabine (XELOX chemotherapy) 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. XELOX chemotherapy with recombinant human endotatin rebombniant human endostatin 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.
- Primary Outcome Measures
Name Time Method Progression free survival 4 years Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival 4 years comparison to maintenance XELOX chemotherapy alone.
local control 4 years To describe local control and out-of-field disease progression
Trial Locations
- Locations (1)
Sichuan Provincial People Hospital
🇨🇳Chengdu, Sichuan, China