Actively Recruiting
Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
Led by Zhejiang Provincial People's Hospital · Updated on 2024-12-09
57
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent
- Age 18-75 years old, any gender
- Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC) with no distant metastasis
- Postoperative pathology showing R0 or R1 resection
- EGFR-positive tumor by immunohistochemistry
- KRAS gene and CDX-2 protein status determined at baseline (for post hoc analysis)
- Adequate organ and bone marrow function: ANC ≥1.5 ×10^9/L; platelets ≥80 ×10^9/L; hemoglobin ≥9.0 g/dL; serum total bilirubin ≤1.5× upper limit of normal (ULN); AST and ALT ≤2.5× ULN; serum creatinine ≤1.5× ULN or creatinine clearance > 60 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected postoperative survival of at least 3 months
- Fertile subjects willing to use contraceptive measures during the study period
You will not qualify if you...
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
- History of other malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix
- Serious diseases such as NYHA grade III or IV heart failure, unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg), active infections, unmanageable diabetes, uncontrolled pleural or pericardial effusion or ascites needing drainage, severe portal hypertension, gastric outlet obstruction, respiratory insufficiency
- Postoperative complications like bleeding, pancreatic fistula, gastric obstruction, abdominal infection, or biliary fistula that prevent adjuvant therapy within 12 weeks after surgery
- CA199 level >180 U/ml within 21 days before adjuvant therapy
- Known allergy to study drugs or their components
- Known HIV, syphilis infection, or active hepatitis B or C
- Other conditions deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yiping Mou, Dr
CONTACT
T
Tao Xia, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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