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

Plain-language summary

This study examines the drug Nimotuzumab combined with Nab-paclitaxel and Gemcitabine chemotherapy after surgery (adjuvant) in patients with EGFR-positive pancreatic cancer. Patients aged 18-75 with surgically resected EGFR-positive pancreatic ductal adenocarcinoma may take part. It is a Phase 2 study that is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Zhejiang Provincial People's Hospital

Intervention

Nimotuzumab, AG

Start date

11/15/2024

Estimated completion

9/30/2028

Countries

China

Related genes

Locations

• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.