Recruiting NCT06722911

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

Phase II Interventional Pancreatic Cancer Resectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nimotuzumab, AG.
Who it may be relevant to: Registry conditions: Pancreatic Cancer Resectable. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Interventions

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.

Primary outcome measures

disease-free survival (DFS) [Time frame: Up to 24 months]

Secondary outcome measures (4)

distant metastasis-free survival (DMFS) [Time frame: Up to 24 months]
overall survival (OS) [Time frame: Up to 24 months]
tumor-related markers [Time frame: Up to 24 months]
adverse events [Time frame: Up to 30 days after last administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

Zhejiang Provincial People's Hospital — Hangzhou

Identifiers

NCT: NCT06722911 · IST-Nim-PC-42

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗