Actively Recruiting
Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer
Led by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Updated on 2025-03-24
512
Participants Needed
5
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining tumor treating fields with chemotherapy drugs gemcitabine and albumin-bound paclitaxel for people with locally advanced pancreatic cancer. This study is a phase 3 clinical trial focusing on patients whose cancer has not spread but meets specific criteria making it difficult to remove surgically. Participants are randomly assigned to one of two groups: one group receives tumor treating fields along with chemotherapy, while the other group receives chemotherapy alone. Chemotherapy cycles last 28 days, with albumin-bound paclitaxel given intravenously on days 1, 8, and 15 at 125 mg/m2, followed immediately by gemcitabine at 1000 mg/m2. Tumor treating fields are used daily until disease progression or for up to 30 months. During the trial, participants will be monitored for overall survival up to 12 months after treatment ends, as well as progression-free survival and adverse events throughout the study period. Researchers will assess measurable lesions, safety, and quality of life. Participants will undergo regular medical evaluations, imaging, and laboratory tests to track treatment effects and side effects over time.
CONDITIONS
Brief Title
Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 75 years, any gender
- Expected survival time of 3 months or more
- Pancreatic adenocarcinoma confirmed by tissue or cell analysis
- Locally advanced pancreatic cancer without distant metastasis meeting specific invasion criteria
- At least one measurable tumor lesion based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Able to receive gemcitabine and albumin-bound paclitaxel chemotherapy
- Able to operate tumor treating fields device independently or with assistance
- Adverse events from prior treatments resolved to normal or grade 1
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after last chemotherapy dose
- Male participants agree to use effective contraception and avoid sperm donation during the study and for 3 months after last chemotherapy dose
- Willing to provide informed consent
You will not qualify if you...
- Prior first-line treatment for pancreatic adenocarcinoma
- Known allergies or contraindications to gemcitabine or albumin-bound paclitaxel
- Other cancers requiring antitumor therapy within 2 years, except certain treated cancers
- Abnormal bone marrow, heart, liver, or kidney function beyond specified limits
- Use of systemic corticosteroids or immunosuppressive agents within 14 days before enrollment, except permitted topical or inhaled steroids
- Severe infection before first dose
- HIV infection
- Active hepatitis B, hepatitis C, or other active infections affecting treatment
- Recent neurological or psychiatric disorders affecting compliance
- Infected, ulcerated, or unhealed skin wounds where tumor treating fields are applied
- Presence of implantable electronic medical devices like pacemakers
- Metal implants in chest or abdomen
- Known allergies to medical adhesives or hydrogels
- Pregnancy or breastfeeding
- Participation in other drug or device clinical trials within specified recent timeframes
- Poor compliance or other factors judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 months
Participants receive gemcitabine hydrochloride and albumin-bound paclitaxel chemotherapy in 28-day cycles. Those in the experimental group also use the tumor treating fields device daily. Treatment continues until disease progression or for a maximum of 30 months.
Visits on Days 1, 8, and 15 of each 28-day cycle for chemotherapy administration; daily use of tumor treating fields device for the experimental group.
Trial Site Locations
Total: 5 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
2
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
5
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
F
Fu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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