Locally Advanced Pancreatic CancerPhase 3NCT05653453
Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer
A Phase 3 study testing Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel and Gemcitabine hydrochloride and albumin binding paclitaxel in people with Locally Advanced Pancreatic Cancer, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel and Gemcitabine hydrochloride and albumin binding paclitaxel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 5 sitesChina
- Study dates
- 20 Dec 2022to 28 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 75 (including 18 and 75) of both genders;
- Expected survival time ≥3 months;
- Pancreatic adenocarcinoma confirmed by histology/cytology;
- 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).
- At least one measurable lesion according to revised RECIST version 1.1;
- ECOG score 0-1;
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- Be able to receive gemcitabine for injection and paclitaxel for injection (albumin-bound) combined therapy according to medical advice;
- Able to operate tumor treating fields independently or with the help of nursing staff;
- AE should be restored to normal or CTCAE1 grade after previous treatment;
- 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;
- 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;
- Voluntarily sign the informed consent.
Who cannot join
- The subjects has previously received first-line treatment for pancreatic adenocarcinoma;
- 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);
- 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;
- 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);
- 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;
- Those who had severe infection before the first dose were judged ineligible for the study by the investigator;
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- History of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive);
- 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;
- 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;
- Infected, ulcerated or unhealed wounds exist on the skin where the tumor treating fields is applied;
- Having an implantable electronic medical device, such as a pacemaker;
- Metal medical instruments are implanted in the chest and abdomen such as bone nails;
- Known allergies to medical adhesives or hydrogels;
- Pregnant or breastfeeding;
- 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;
- Subjects with poor compliance or other factors as judged by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, 200040
- Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Fu, 021-52889999, Surgeonfu@163.com
About this study
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
- Locally Advanced Pancreatic Cancer
- Being tested
- Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel, Gemcitabine hydrochloride and albumin binding paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxelDevice
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.
Gemcitabine hydrochloride and albumin binding paclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel | Experimental | Device: Tumor treating fields Subjects will use tumor treating fields each day
Drug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously，1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel. Receives: Device: Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel; Drug: Gemcitabine hydrochloride and albumin binding paclitaxel |
| Gemcitabine hydrochloride and albumin binding paclitaxel | Active comparator | Drug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously，1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel. Receives: Drug: Gemcitabine hydrochloride and albumin binding paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
From date of enrollment until the date of death from any cause
Measured: up to 12 months after the last study treatment
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments
Measured: The whole study period
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with Tumor Treating Fields and Docetaxel until the first documentation of disease progression or death due to any cause, whichever occurs first
Measured: up to 30 months
12-month OS rate
12-month Overall survival rate
Measured: 12 months
Progression Free Survival rate at 6 months
The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Dec 2022
- Primary completion25 Dec 2026 (estimated)
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653453
- Sponsor's protocol ID
- P100-LAPC1
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05653453
- Acronym / sponsor ID
- P100-LAPC1
- Conditions
- Locally Advanced Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel | Experimental | Device: Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel, Drug: Gemcitabine hydrochloride and albumin binding paclitaxelDevice: Tumor treating fields Subjects will use tumor treating fields each day Drug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously，1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel. |
| Gemcitabine hydrochloride and albumin binding paclitaxel | Active comparator | Drug: Gemcitabine hydrochloride and albumin binding paclitaxelDrug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously，1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects aged between 18 and 75 (including 18 and 75) of both genders;
- Expected survival time ≥3 months;
- Pancreatic adenocarcinoma confirmed by histology/cytology;
- 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).
- At least one measurable lesion according to revised RECIST version 1.1;
Key exclusion criteria (16 listed)
- The subjects has previously received first-line treatment for pancreatic adenocarcinoma;
- 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);
- 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;
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxelDevice: 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. | Device | Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel |
| Gemcitabine hydrochloride and albumin binding paclitaxelDrug: 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, Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel |
Primary outcome
Overall survival (OS)
Time frame: up to 12 months after the last study treatment
From date of enrollment until the date of death from any cause
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: The whole study period
Progression-free survival (PFS)
Time frame: up to 30 months
12-month OS rate
Time frame: 12 months
Progression Free Survival rate at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel and Gemcitabine hydrochloride and albumin binding paclitaxel in people with Locally Advanced Pancreatic Cancer, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu (021-52889999, Surgeonfu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 12 months after the last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.