Clinical trial · Interventional
Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
NCT06722911CI-TRIAL-00083467recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AG | Drug | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab+ AG
- interventionNames
- Drug: Nimotuzumab
- Drug: AG
Primary outcomes (1)
- measure
- disease-free survival (DFS)
- timeFrame
- Up to 24 months
- description
- The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Secondary outcomes (4)
- measure
- distant metastasis-free survival (DMFS)
- timeFrame
- Up to 24 months
- description
- The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.