Clinical trial NCT05316480: Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms
Official title: Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Neuroendocrine Neoplasm
Keywords: EGFR
nimotuzumab
Pancreatic Neuroendocrine Neoplasm
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
4. 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.
5. Male or female, 18 years of age or older.
6. ECOG performance status less than 2.
7. Life expectancy greater than 12 weeks.
8. 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
9. 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.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Active second primary malignancy or history of second primary malignancy.
2. Current treatment on another clinical trial.
3. 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.
4. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
5. Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.
6. Patients who are unwilling or unable to comply with study procedures.
7. Prior targeted treatment on EGFR.
8. Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Baseline to 6 months
measure: Progression free survival (PFS)
timeFrame: Patients will be followed until disease progression, estimating around 12months
measure: Overall survival (OS)
timeFrame: Patients will be followed until disease progression, estimating around 12months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
Study officials:
References: