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Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Primary Purpose

Pancreatic Neuroendocrine Neoplasm

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

About this trial

This is an interventional treatment trial for Pancreatic Neuroendocrine Neoplasm focused on measuring EGFR, nimotuzumab, Pancreatic Neuroendocrine Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab

Arm Description

nimotuzumab 200mg/week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Progression free survival (PFS)

Overall survival (OS)

Full Information

NCT ID

NCT05316480

First Posted

March 28, 2022

Last Updated

April 4, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05316480

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neuroendocrine Neoplasm

Keywords

EGFR, nimotuzumab, Pancreatic Neuroendocrine Neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab

Arm Type

Experimental

Arm Description

nimotuzumab 200mg/week

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Intervention Description

nimotuzumab 200mg/week

Primary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

Time Frame

Baseline to 6 months

Secondary Outcome Measure Information:

Title

Disease control rate (DCR)

Description

Time Frame

Baseline to 6 months

Title

Progression free survival (PFS)

Time Frame

Patients will be followed until disease progression, estimating around 12months

Title

Overall survival (OS)

Time Frame

Patients will be followed until disease progression, estimating around 12months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

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