Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms
ConditionPancreatic Neuroendocrine Neoplasm
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Nimotuzumab
Drugnimotuzumab 200mg/week
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: NimotuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Disease control rate (DCR)
Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.
Time frame
Baseline to 6 months2
Progression free survival (PFS)
Time frame
Patients will be followed until disease progression, estimating around 12months3
Overall survival (OS)
Time frame
Patients will be followed until disease progression, estimating around 12monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: