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Status unknownNCT01899118Updated Jul 15, 2013

Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

A Phase 2 interventional study of Preoperative irradiation and Nimotuzumab in Locally Advanced Rectal Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-15.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.

02

Conditions studied

  • Locally Advanced Rectal Cancer

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Keywords

  • locally advanced rectal cancer
  • Neoadjuvant chemoradiotherapy
  • Nimotuzumab
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 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

  1. Written informed consent
  2. Age:18-75 years
  3. Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
  4. The lower edge of the tumors located below 12 cm from the anal verge
  5. Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
  6. No prior chemotherapy was used
  7. No history of regional radiation treatment inthe pelvic cavity
  8. Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L,PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
  9. Patients without peripheral neuropathy

Exclusion criteria

Exclusion Criteria:

  1. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
  2. Rectal cancer patients with concurrent colon cancer
  3. Pregnant or lactating women
  4. Fertile female patients without using any contraceptives
  5. Allergic to cisplatin and fluorouracil
  6. Patients with previous peripheral neuropathy
  7. Serious complications: myocardial infarction, heart failure (NYHA Classification>II grade),psychiatric history and severe diabetes
  8. Treatment with other anti-cancer therapy(including Chinese herbal medicine)
  9. Organ transplant patients
05

Study design

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

Study arms

  • Experimental
    Nimotuzumab plus chemoradiotherapy

    Radiation: Preoperative irradiation · Drug: Nimotuzumab · Drug: Oxaliplatin · Drug: Capecitabine

Interventions

  • RadiationPreoperative irradiation

    50.4Gy/28F/5.5w

  • DrugNimotuzumab

    400mg/w,0-5w

  • DrugOxaliplatin

    130mg/m2 d1

  • DrugCapecitabine

    825mg/m2 bid d1-5/w,1-5w

06

What researchers measure

Primary outcomes

  1. Pathology complete remission rate

    Pathology complete remission rate is the primary outcome measure.

    Time frame: 1 year

Secondary outcomes

  1. tumor regression rate

    Time frame: 1 year

  2. local recurrence rate

    Time frame: 5 years

  3. overall survival

    Time frame: 5 years

  4. sphincter preservation rate

    Time frame: 3 years

  5. Incidence of Adverse Events

    Time frame: up to 1 month after the last cycle

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    • Jialin Luo, MD · Contact · 0086-571-88122062
    • Yuan Zhu, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01899118
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Jul 15, 2013
Start date
Apr 2013
Primary completion
Apr 2016 (estimated)
Last update
Jul 15, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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