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
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Objectives of this clinical trial is to evaluate the efficacy and safety of tumor treating fields combined with gemcitabine and albumin bound paclitaxel in the treatment of locally advanced pancreatic cancer.
CONDITIONS
Official 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...
- Aged between 18 and 75 years, any gender
- Expected survival time of at least 3 months
- Diagnosed with pancreatic adenocarcinoma confirmed by histology or cytology
- Locally advanced tumor without distant metastasis meeting specific vascular invasion criteria
- At least one measurable lesion according to RECIST version 1.1
- ECOG performance status score of 0 or 1
- Able to receive gemcitabine and albumin-bound paclitaxel combination therapy
- Able to operate tumor treating fields device independently or with nursing support
- Adverse events from prior treatments recovered to normal or grade 1
- Negative serum pregnancy test for women of reproductive age, with agreement to use contraception during study and 6 months after
- Male subjects agree to use effective contraception during study and for 3 months after last chemotherapy dose
- Voluntarily sign informed consent
You will not qualify if you...
- Previously received first-line treatment for pancreatic adenocarcinoma
- Contraindications or severe allergies to gemcitabine or albumin-bound paclitaxel
- Cancer requiring other antitumor therapy within 2 years before enrollment (except specific early-stage cancers)
- Abnormal bone marrow, heart, liver, or kidney function by defined lab thresholds
- Required systemic corticosteroids (>10 mg prednisone/day) or immunosuppressive agents within 14 days before enrollment or during study (with some exceptions)
- Severe infection before first dose as judged by investigator
- History of HIV infection
- Active hepatitis B, hepatitis C, or other infections affecting treatment
- History of neurological or psychiatric disorders affecting compliance within last year
- Infected, ulcerated, or unhealed skin wounds at tumor treating fields application sites
- Implantable electronic medical devices such as pacemakers
- Metal medical implants in chest or abdomen
- Known allergies to medical adhesives or hydrogels
- Pregnant or breastfeeding
- Participation in other drug clinical trials within 3 months or device trials within 1 month before enrollment
- Poor compliance or other factors judged by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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