A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )

Study Overview
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Brief Summary
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This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer. This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.

Official Title
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A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Albumin-bound paclitaxel
* Drug: S-1
* Drug: Oxaliplatin
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily participate in the trial and sign the informed consent form 18 years old <age <75 years old Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria ECOG score 0-1 Life expectancy > 3 months There must be a CT or MRI examination within a week at least one lesion that can be measured by the RECIST v1.1 standard No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months) without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area) Exclusion Criteria: pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures; Severe active infections requiring intravenous antibiotic treatment during enrollment; those who are allergic to the test drug; There is ≥2 neuropathy (CTCAE 4.0); uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction; Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack; Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled; Patients who are unable to follow the protocol or who are unable to follow up;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles | Drug: Albumin-bound paclitaxel<br>* Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.<br>Drug: S-1<br>* a combination preparation of tegafur, gimeracil, and oteracil potassium<br>Drug: Oxaliplatin<br>* The compound features a square planar platinum(II) center. In contrast to cisplatin and carboplatin, oxaliplatin features the bidentate ligand 1,2-diaminocyclohexane in place of the two monodentate ammine ligands. It also features a bidentate oxalate group.<br>Drug: Gemcitabine<br>* Gemcitabine is a synthetic pyrimidine nucleoside prodrug-a nucleoside analog in which the hydrogen atoms on the 2' carbon of deoxycytidine are replaced by fluorine atoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | from the first drug administration up to 6 months | 
| OS | overall survival | from the first drug administration up to 1 year |