Clinical trial NCT06722911: Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
Official title: Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer Resectable
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 \&gt; 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\&gt;160mmHg or DBP\&gt;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\&gt;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\&#39;s judgment.

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: distant metastasis-free survival (DMFS)
timeFrame: Up to 24 months
measure: overall survival (OS)
timeFrame: Up to 24 months
measure: tumor-related markers
timeFrame: Up to 24 months
measure: adverse events
timeFrame: Up to 30 days after last administration
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Yiping Mou, Dr
role: STUDY_CHAIR
References: