Clinical trial · Interventional
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
NCT01832948CI-TRIAL-00010058unknownPhase 2ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
| Folinic acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
- interventionNames
- Drug: Endostar
- Drug: Oxaliplatin
- Drug: Folinic acid
- Drug: 5-FU
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- the end of the 3rd cycle
Secondary outcomes (3)
- measure
- Blood perfusion in tumor tissue
- timeFrame
- baseline, the end of the 3rd cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.