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

Phase 2RecruitingNCT06722911

Zhejiang Provincial People's Hospital57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Resectable

Interventions

NimotuzumabDRUG

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.

AGDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

disease-free survival (DFS)

The time from the date of surgery to the disease recurrence or death, whichever is earlier.

Time frame: Up to 24 months

Secondary Outcomes

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.

Time frame: Up to 24 months

overall survival (OS)

The time from the date of surgery to death due to any cause.

Time frame: 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.

Time frame: Up to 24 months

adverse events

Frequency and severity of adverse events.

Time frame: Up to 30 days after last administration

Central Contacts

Yiping Mou, Dr

CONTACT

0086-057185893643 mouyiping@hmc.edu.cn

Tao Xia, Dr

CONTACT

Data from ClinicalTrials.gov

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