Study Of Adjuvant Nimotuzumab Combined With Nab-paclitaxel+ Gemcitabine In EGFR-positive Pancreatic Cancer

Study Overview

Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer

This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.

This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

Pancreatic Cancer Resectable

DRUG: Nimotuzumab
DRUG: AG

IST-Nim-PC-42

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-12-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-04
First Submitted that Met QC Criteria 2024-12-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-09
First Posted (ACTUAL) 2024-12-09	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nimotuzumab+ AG	DRUG: Nimotuzumab Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unac DRUG: AG Patients will receive nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1,000 mg/m^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of di

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nimotuzumab+ AG

DRUG: Nimotuzumab

Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unac

DRUG: AG

Patients will receive nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1,000 mg/m^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of di

Primary Outcome Measures	Measure Description	Time Frame
disease-free survival (DFS)	The time from the date of surgery to the disease recurrence or death, whichever is earlier.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
distant metastasis-free survival (DMFS)	The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.	Up to 24 months
overall survival (OS)	The time from the date of surgery to death due to any cause.	Up to 24 months
tumor-related markers	To explore the influence of tumor-related markers (such as KRAS gene, CDX-2 protein, etc.) on prognosis.	Up to 24 months
adverse events	Frequency and severity of adverse events.	Up to 30 days after last administration

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yiping Mou, Dr

Phone Number: 0086-057185893643

Email: mouyiping@hmc.edu.cn

Study Contact Backup

Name: Tao Xia, Dr

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1. Able and willing to provide a written informed consent.
2. Age 18-75 years old, gender unlimited;
3. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
4. Postoperative pathology suggested R0/R1 resection;
5. EGFR positive (by immunohistochemistry);
6. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥80×10^9/L; hemoglobin≥9.0 g/dL; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Postoperative survival is expected to be ≥3 months;
10. Fertile subjects are willing to take contraceptive measures during the study period.

1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
4. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
5. CA199>180 U/ml within 21d before adjuvant therapy;
6. Known allergy to prescription or any component of the prescription used in this study;
7. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
8 .Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Yiping Mou, Dr, Zhejiang Provincial People's Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record