NCT05278728

Brief Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Jul 2009

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
6.6 years until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

August 18, 2015

Last Update Submit

February 5, 2025

Conditions

Colorectal Cancer

Keywords

nimotuzumabcolorectal cancerchemotherapy

Outcome Measures

Primary Outcomes (1)

  • The rate of grade 3/4 toxicity

    The rate of grade 3/4 toxicity, defined as the proportion or frequency of patients who experience toxicity reactions that are classified as grade 3 or grade 4 according to CTCAE v5.0.

    3 months

Secondary Outcomes (4)

  • Maximum Tolerated Dose (MTD)

    3 months

  • The complete response rate

    3 months

  • The partial response rate

    3 months

  • The disease control rate

    3 months

Study Arms (1)

Nimotuzumab and Irinotecan

EXPERIMENTAL

Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Drug: NimotuzumabDrug: Irinotecan

Interventions

NimotuzumabDRUG

200,400,600 or 800mg weekly until progression or AEs

Nimotuzumab and Irinotecan
IrinotecanDRUG

180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Nimotuzumab and Irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent form signed before performing any of the study's specific procedures.
  • ECOG performance status 0-2.
  • Age \> 18，both genders.
  • Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
  • Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
  • At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
  • Life expectancy more than 3 months.
  • K-ras is wild type
  • Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  • Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
  • Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
  • TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
  • No brain metastasis

You may not qualify if:

  • Previous radiotherapy at lesions within three months
  • Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
  • Received other anti EGFR monoclonal antibody treatment
  • Complete or incomplete intestinal obstruction
  • Participation in other interventional clinical trials within 1 month
  • Psychiatric disease affected cognitive ability, including brain metastasis
  • Peripheral neuropathy lesion is more than I stage.
  • History of serious allergic or allergy
  • Pregnant or breast-feeding women
  • Patients with the history of Serious lung or hear disease
  • Other malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China People's Liberation Army (PLA)81 Hospital

Nanjing, Jiangsu, China

Location

Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Beijing, 100036, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nimotuzumabIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Lin Shen

    Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

March 14, 2022

Study Start

July 1, 2009

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

CN(2)