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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer

Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer (NCT05653453) is a Phase 3 interventional studying Locally Advanced Pancreatic Cancer, sponsored by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Locally Advanced Pancreatic Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 512 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects aged between 18 and 75 (including 18 and 75) of both genders; 2. Expected survival time ≥3 months; 3. Pancreatic adenocarcinoma confirmed by histology/cytology; 4. Locally advanced lesions meeting any of the following criteria without distant metastasis: ① Pancreatic head and neck tumors: a. The tumor invaded the Superior Mesenteric Artery (SMA) more than 180°; b. The tumor invaded the celiac trunk more than 180°; c. Unresectable reconstruction of superior mesenteric vein or portal vein due to tumor invasion or embolism (tumor thrombus or thrombus); d. The tumor extensively invaded the distal jejunal drainage branch of the superior mesenteric vein. ② Pancreatic body/tail tumor: a. The tumor invaded the superior mesenteric artery or celiac trunk more than 180°; b. Celiac trunk and abdominal aorta involvement; c. The superior mesenteric vein or portal vein cannot be resected and reconstructed due to tumor invasion or embolism (tumor thrombus or thrombus). 5. At least one measurable lesion according to revised RECIST version 1.1; 6. ECOG score 0-1; 7. Be able to receive gemcitabine for injection and paclitaxel for injection (albumin-bound) combined therapy according to medical advice; 8. Able to operate tumor treating fields independently or with the help of nursing staff; 9. AE should be restored to normal or CTCAE1 grade after previous treatment; 10. The serum pregnancy test results of female subjects of reproductive age were negative. Female subjects of reproductive age agree to use effective contraception (e.g. hormonal or barrier methods or abstinence) during the study period and for 6 months after the last dose of chemotherapy drugs; 11. Male subjects agree to use effective birth control (such as barrier method or abstinence) and not to donate sperm during the study and within 3 months after the last chemotherapy drug administration; 12. Voluntarily sign the willing to sign a consent form. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subjects aged between 18 and 75 (including 18 and 75) of both genders; 2. Expected survival time ≥3 months; 3. Pancreatic adenocarcinoma confirmed by histology/cytology; 4. Locally advanced lesions meeting any of the following criteria without distant metastasis: ① Pancreatic head and neck tumors: a. The tumor invaded the Superior Mesenteric Artery (SMA) more than 180°; b. The tumor invaded the celiac trunk more than 180°; c. Unresectable reconstruction of superior mesenteric vein or portal vein due to tumor invasion or embolism (tumor thrombus or thrombus); d. The tumor extensively invaded the distal jejunal drainage branch of the superior mesenteric vein. ② Pancreatic body/tail tumor: a. The tumor invaded the superior mesenteric artery or celiac trunk more than 180°; b. Celiac trunk and abdominal aorta involvement; c. The superior mesenteric vein or portal vein cannot be resected and reconstructed due to tumor invasion or embolism (tumor thrombus or thrombus). 5. At least one measurable lesion according to revised RECIST version 1.1; 6. ECOG score 0-1; 7. Be able to receive gemcitabine for injection and paclitaxel for injection (albumin-bound) combined therapy according to medical advice; 8. Able to operate tumor treating fields independently or with the help of nursing staff; 9. AE should be restored to normal or CTCAE1 grade after previous treatment; 10. The serum pregnancy test results of female subjects of reproductive age were negative. Female subjects of reproductive age agree to use effective contraception (e.g. hormonal or barrier methods or abstinence) during the study period and for 6 months after the last dose of chemotherapy drugs; 11. Male subjects agree to use effective birth control (such as barrier method or abstinence) and not to donate sperm during the study and within 3 months after the last chemotherapy drug administration; 12. Voluntarily sign the informed consent. Exclusion Criteria: 1. The subjects has previously received first-line treatment for pancreatic adenocarcinoma; 2. Subjects with contraindications to treatment with gemcitabine for injection and/or paclitaxel for injection (albumin-bound) or known severe allergies to gemcitabine for injection and/or paclitaxel for injection (albumin-bound); 3. Patients had cancer requiring other antitumor therapy within 2 years before enrollment, excluding treated stage I prostate cancer, cervical cancer in situ, breast cancer in situ, and non-melanoma skin cancer; 4. Abnormal bone marrow, heart, liver and kidney function: a. Neutrophil count \< 1.5 × 10\^9/L, platelet count \< 100 × 10\^9/L, hemoglobin \< 90g/L; The use of blood transfusion, platelet transfusion and erythropoietin was prohibited within 14 days before C1D1, and the use of Leukocytotropic drug such as G-CSF, fegrasstim, pefegrasstim, etc., was prohibited within 7 days before C1D1.b. Total bilirubin \> 1.5× Upper Limit of Normal (ULN); Subjects with a total bilirubin \> 2×ULN that is elevated due to pancreatic cancer compression of the bile duct but has been fitted with a bile duct stent for drainage can be enrolled. AST and/or ALT\> 2.5×ULN; the use of drugs that improve liver function, such as reducing transaminase was prohibited within 7 days before C1D1. c. Serum creatinine \> 1.5×ULN; d. A history of severe cardiovascular disease, including but not limited to second or third degree heart block; Severe ischemic heart disease; New York Heart Association (NYHA) class II or higher congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing); 5. Subjects who were required to receive systemic corticosteroids (doses equivalent to \> 10 mg prednisone/day) or other immunosuppressive agents within 14 days before enrollment or during the study period. Subjects were eligible for enrollment if: a. The use of topical or inhaled glucocorticoids is permitted; b. Allow short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases; 6. Those who had severe infection before the first dose were judged ineligible for the study by the investigator; 7. History of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive); 8. The presence of active hepatitis B, active hepatitis C, or other active infections that may affect the patient's treatment as determined by the investigator; 9. Subjects with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, or substance abuse (including alcohol) within the last year, and possibly affecting compliance; 10. Infected, ulcerated or unhealed wounds exist on the skin where the tumor treating fields is applied; 11. Having an implantable electronic medical device, such as a pacemaker; 12. Metal medical instruments are implanted in the chest and abdomen such as bone nails; 13. Known allergies to medical adhesives or hydrogels; 14. Pregnant or breastfeeding; 15. Subjects participated in clinical trials of other drugs within 3 months before enrollment, or participated in clinical trials of other devices within 1 month before enrollment; 16. Subjects with poor compliance or other factors as judged by the investigator.

Treatments Being Tested

DEVICE

Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel

Device: Tumor treating fields Subjects will use tumor treating fields until disease progression or for a maximum of 30 months. Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.

DRUG

Gemcitabine hydrochloride and albumin binding paclitaxel

Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05653453), the sponsor (Jiangsu Healthy Life Innovation Medical Technology Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05653453 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05653453?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05653453?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05653453. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05653453. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.