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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From date of enrollment until the date of death from any cause | up to 12 months after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The whole study period |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu | Contact | 021-52889999 | Surgeonfu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China | |
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| Gemcitabine hydrochloride and albumin binding paclitaxel | Drug | 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. |
|
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
| up to 30 months |
| 12-month OS rate | 12-month Overall survival rate | 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 | 6 months |
| Cancer Hospital of Shandong First Medical University |
| Recruiting |
| Jinan |
| Shandong |
| 250117 |
| China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Fudan University Affiliated Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| Huashan Hospital Affiliated to Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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