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

Recruiting now · Phase 2

Conditions studied: Pancreatic Cancer Resectable

In brief

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.

Key facts

Study ID

NCT06722911

Run by

Zhejiang Provincial People's Hospital

People needed

57

Starts

2024-11-15

Expected to finish

2028-09-30

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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