Actively Recruiting
Nimotuzumab Combined with Nab-paclitaxel and Gemcitabine as Postoperative Adjuvant Therapy in EGFR-positive Pancreatic Cancer: A Prospective Single-Arm Study
Led by Zhejiang Provincial People's Hospital · Updated on 2024-12-09
57
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Nimotuzumab with nab-paclitaxel and gemcitabine (AG regimen) as a postoperative adjuvant treatment for patients with EGFR-positive pancreatic cancer. This open-label, single-arm phase II study aims to assess the efficacy and safety of this combination, focusing on disease-free survival as the main outcome. Additional goals include evaluating distant metastasis-free survival, overall survival, tumor markers, and safety measures. Participants will receive Nimotuzumab doses of 400 mg on Days 1 and 15 in a 28-day cycle for six cycles, along with nab-paclitaxel 125 mg/m² and gemcitabine 1,000 mg/m² given intravenously on Days 1 and 8 of a 21-day cycle for six cycles. Treatment will continue unless imaging shows disease recurrence or unacceptable side effects occur. During the study, participants will undergo regular assessments including imaging to monitor disease status and blood tests to check tumor markers and safety. Researchers will track adverse events for 30 days after the last treatment and follow participants for up to 24 months to evaluate survival and disease progression. Total study duration includes these monitoring and treatment periods.
CONDITIONS
Brief 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 written informed consent
- Age 18 to 75 years, any gender
- Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC) with no distant metastasis
- Postoperative pathology showing R0 or R1 resection
- EGFR positive confirmed by immunohistochemistry
- KRAS gene and CDX-2 protein status determined at baseline (for analysis)
- Adequate organ and bone marrow function meeting specific blood and chemistry levels
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected postoperative survival of at least 3 months
- Fertile participants agree 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 or carcinoma in situ of the cervix
- Serious diseases such as severe heart failure, unstable angina, uncontrolled arrhythmias or hypertension, active infections, uncontrolled diabetes, or severe portal hypertension
- Postoperative complications preventing adjuvant therapy within 12 weeks after surgery
- CA199 level greater than 180 U/ml within 21 days before adjuvant therapy
- Known allergy to any study drug or its components
- Known HIV, syphilis infection, or active hepatitis B or C
- Other conditions deemed unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Six 21-day cycles unless disease recurrence or unacceptable toxicity occurs
Participants receive Nimotuzumab combined with nab-paclitaxel and gemcitabine as postoperative adjuvant therapy.
Visits on Days 1 and 8 of each 21-day cycle for up to 6 cycles
Duration - Up to 24 months after treatment
Participants are monitored for disease-free survival, distant metastasis-free survival, overall survival, tumor markers, and adverse events after treatment ends.
Visits up to 24 months post-treatment with assessments as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yiping Mou, Dr
T
Tao Xia, Dr
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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