Clinical trial · Interventional
Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
NCT03577392CI-TRIAL-00037940EXECCunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin + capecitabine (XELOX chemotherapy) | Drug | — | UNRESOLVED |
| rebombniant human endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XELOX chemotherapy with recombinant human endotatin
- 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.
- interventionNames
- Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
- Drug: rebombniant human endostatin
- type
- ACTIVE_COMPARATOR
- label
- XELOX chemotherapy without recombinant human endotatin
- 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.
- interventionNames
- Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.