Actively Recruiting
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-10-31
57
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.
CONDITIONS
Official Title
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Complete macroscopic resection for pancreatic cancer (R0 or R1) confirmed by histology with no distant metastasis shown by imaging
- No prior tumor therapy
- Adequate organ and bone marrow function: WBC ≥ 3.0×10⁹/L; ANC ≥ 1.5×10⁹/L; hemoglobin ≥ 9.0 g/dL; platelets ≥ 75×10⁹/L; total bilirubin ≤ 1.5 times upper limit of normal; AST and ALT ≤ 2.5 times upper limit of normal; serum creatinine ≤ 1 times upper limit of normal or creatinine clearance ≥ 50 mL/min
- Left ventricular ejection fraction ≥ 50%
- Fertile participants agree to use contraceptive measures during the study
- Good compliance and signed informed consent voluntarily
You will not qualify if you...
- Prior systemic anti-tumor therapy such as chemotherapy or radiotherapy
- Participation in other drug clinical trials within the last 4 weeks
- History of other malignancies
- Immunodeficiency or immune-related disorders needing medical treatment
- Postoperative complications such as bleeding
- Pregnant or breastfeeding women
- Drug abuse or clinical, psychological, or social factors that could affect informed consent or study participation
- Known allergy to nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, capecitabine, or any study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
J
Juan Du, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here