Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01832948

Enrollment

Registered

2013-04-16

Start date

2013-01-31

Completion date

2015-01-31

Last updated

2013-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Brief summary

This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.

Interventions

DRUGEndostar

DRUGOxaliplatin

DRUGFolinic acid

DRUG5-FU

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma) * At least one measurable lesion (RECIST criteria) * Life expectancy ≥ 3 months * ECOG performance status 0-2 * Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L * Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min * Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN * Patients have not previously received palliative chemotherapy, immunological/ biological treatment * No adjuvant chemotherapy in last six months * Target lesion has not received local radiotherapy * Written informed consent

Exclusion criteria

* Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma * Evidence of serious or uncontrolled infection * Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * Pregnant or lactating women * Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy * Allergic to any of the study drug * Intestinal obstruction, intestinal perforation, or stroke within 3 months * Participation in other clinical studies

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR)	the end of the 3rd cycle

Secondary

Measure	Time frame
Blood perfusion in tumor tissue	baseline, the end of the 3rd cycle
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue	baseline, the end of the 3rd cycle
Incidence of Adverse Events	up to 1 month after the last cycle

Countries

China

Contacts

Primary ContactLiming Zhu, MD

0571-88122222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026