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

NCT03577392 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-04-04

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Ke Xie, MD PhD · Sichuan Provincial People Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-08-01
Completion
2021-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577392 on ClinicalTrials.gov