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

Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer Resectable
• Intervention / Treatment: Drug: Nimotuzumab; Drug: AG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yiping Mou, Dr; Phone Number: 0086-057185893643; Email: mouyiping@hmc.edu.cn
• Study Contact Backup: Name: Tao Xia, Dr

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Yiping Mou; Phone Number: 0086-057185893643; Email: mouyiping@hmc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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 unacceptable toxicity.; 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 disease recurrence and unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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
adverse events	Frequency and severity of adverse events.	Up to 30 days after last administration
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

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Investigators: Study Chair: Yiping Mou, Dr, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Nimotuzumab
• Other Study ID Numbers: IST-Nim-PC-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No