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

Zhejiang Provincial People's Hospital

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Cancer Resectable

Treatments

Drug: AG

Drug: Nimotuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT06722911

IST-Nim-PC-42

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent.
1. Age 18-75 years old, gender unlimited;
1. 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;
1. Postoperative pathology suggested R0/R1 resection;
1. EGFR positive (by immunohistochemistry);
1. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
1. 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;
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
1. Postoperative survival is expected to be ≥3 months;
1. 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;
1. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
1. 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;
1. 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;
1. CA199>180 U/ml within 21d before adjuvant therapy;
1. Known allergy to prescription or any component of the prescription used in this study;
1. 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.