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Status unknownNCT01486992Updated Jan 12, 2012

mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus

A Phase 2 interventional study of mFOLFIRI+Nimotuzumab in Advanced Esophageal Carcinoma, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-01-12.

Sponsored by Peking University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

02

Conditions studied

  • Advanced Esophageal Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
  • Age 18 to 75 years old
  • Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  • Life expectancy of ≥3 month
  • Karnofsky performance status ≥80
  • WBC>3,500/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
  • Normal ECG/cardiac function
  • Good compliance
  • Having signed informed consent

Exclusion criteria

Exclusion Criteria:

  • More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
  • Known hypersensitivity to study drugs
  • Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  • No measurable lesions, eg. pleural fluid and ascites
  • Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
  • Chronic diarrhea
  • Mentally abnormal or disable cognition,including CNS metastasis
  • Pregnancy or lactation period
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Nimotuzumab

    irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw

    Drug: mFOLFIRI+Nimotuzumab

Interventions

  • DrugmFOLFIRI+Nimotuzumab

    irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 2 years

  2. adverse events

    Time frame: 2 weeks

Secondary outcomes

  1. progression-free survival

    Time frame: 1year

  2. response rate

    Time frame: 6 weeks

  3. disease control rate

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Zhang Xiaodong
    Beijing, Beijing 100142, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01486992
Lead sponsor
Peking University
Responsible party
Shen Lin (HEAD OF GI ONCOLOGY, Peking University) — Principal investigator
First posted
Dec 7, 2011
Start date
Nov 2011
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Jan 12, 2012

Study contacts

xiaodong zhang, MD
Contact
zxd0829@yahoo.com.cn
861088196175

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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