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Not yet recruiting NCT05316480

Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Phase II Interventional Pancreatic Neuroendocrine Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nimotuzumab.
Who it may be relevant to
Registry conditions: Pancreatic Neuroendocrine Neoplasm. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Overview

The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Detailed description

Nimotuzumab (hR3) 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 various types of cancer with EGFR overexpression. The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Interventions

  • Drug Nimotuzumab
    nimotuzumab 200mg/week

Primary outcome measures

  • Overall response rate (ORR) [Time frame: Baseline to 6 months]
Secondary outcome measures (3)
  • Disease control rate (DCR) [Time frame: Baseline to 6 months]
  • Progression free survival (PFS) [Time frame: Patients will be followed until disease progression, estimating around 12months]
  • Overall survival (OS) [Time frame: Patients will be followed until disease progression, estimating around 12months]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with well and moderately differentiated with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
  • Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.
  • Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
  • Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
  • Male or female, 18 years of age or older.
  • ECOG performance status less than 2.
  • Life expectancy greater than 12 weeks.
  • The definitions of minimum adequacy for organ function required prior to study entry are as follows.

Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin < 1.5 x ULN Serum albumin > 3.0 g/dL Absolute neutrophil count (ANC) > 1500/L Hemoglobin > 9.0 g/dL Creatinin clearance < 40 mL/min

  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

  • Active second primary malignancy or history of second primary malignancy.
  • Current treatment on another clinical trial.
  • Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
  • Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
  • Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.
  • Patients who are unwilling or unable to comply with study procedures.
  • Prior targeted treatment on EGFR.
  • Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Canc — Shanghai

Identifiers

NCT: NCT05316480 · PTCA199-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗