BridgeMD
New treatment option for Pancreatic Cancer Resectable
Official title Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
ClinicalTrials.gov ID: NCT06722911
What this study is testing
What is Nimotuzumab?
Nimotuzumab is an investigational medicine, being studied as a potential treatment for pancreatic cancer resectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- 4\. Postoperative pathology suggested R0/R1 resection;
- 5\. EGFR positive (by immunohistochemistry);
You likely can't join 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...
- 4\. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the...
- 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;
See the full eligibility 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...
- 8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 9\. Postoperative survival is expected to be ≥3 months;
- 10\. Fertile people are willing to take contraceptive measures during the study period.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.