RecruitingPhase 2NCT06722911

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

Sponsor

Zhejiang Provincial People's Hospital

Enrollment

57 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Resectable

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

\. Able and willing to provide a written informed consent.
\. Age 18-75 years old, gender unlimited;
\. 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;
\. Postoperative pathology suggested R0/R1 resection;
\. EGFR positive (by immunohistochemistry);
\. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
\. 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;
\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
\. Postoperative survival is expected to be ≥3 months;
\. Fertile subjects are willing to take contraceptive measures during the study period.

Exclusion Criteria8

\. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
\. 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;
\. 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;
\. CA199\>180 U/ml within 21d before adjuvant therapy;
\. Known allergy to prescription or any component of the prescription used in this study;
\. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
.Other reasons that are not suitable to participate in this study according to the researcher\'s judgment.

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Interventions

DRUGNimotuzumab

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.

DRUGAG

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.