NCT06722911 Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
| NCT ID | NCT06722911 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Pancreatic Cancer Resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 57 participants in total. It began in 2024-11-15 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 \> 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.
Contact & Investigator
Yiping Mou, Dr
STUDY CHAIR
Zhejiang Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06722911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer Resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06722911 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06722911 currently recruiting?
Yes, NCT06722911 is actively recruiting participants. Contact the research team at mouyiping@hmc.edu.cn for enrollment information.
Where is the NCT06722911 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06722911 clinical trial?
NCT06722911 is sponsored by Zhejiang Provincial People's Hospital. The principal investigator is Yiping Mou, Dr at Zhejiang Provincial People's Hospital. The trial plans to enroll 57 participants.
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