A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
NCT ID: NCT03825328
Last Updated: 2019-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2019-01-30
2020-12-30
Brief Summary
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This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
Albumin-bound paclitaxel
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
S-1
a combination preparation of tegafur, gimeracil, and oteracil potassium
Oxaliplatin
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.
Gemcitabine
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.
Interventions
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Albumin-bound paclitaxel
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
S-1
a combination preparation of tegafur, gimeracil, and oteracil potassium
Oxaliplatin
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.
Gemcitabine
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.
Eligibility Criteria
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Inclusion Criteria
2. 18 years old \<age \<75 years old
3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
4. ECOG score 0-1
5. Life expectancy \> 3 months
6. There must be a CT or MRI examination within a week
7. at least one lesion that can be measured by the RECIST v1.1 standard
8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)
Exclusion Criteria
2. Severe active infections requiring intravenous antibiotic treatment during enrollment;
3. those who are allergic to the test drug;
4. There is ≥2 neuropathy (CTCAE 4.0);
5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
7. 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;
8. Patients who are unable to follow the protocol or who are unable to follow up;
18 Years
75 Years
ALL
No
Sponsors
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Yanqiao Zhang
OTHER
Responsible Party
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Yanqiao Zhang
Director of the hospital
Central Contacts
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Other Identifiers
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HZ-NS/GEMOX-PC
Identifier Type: -
Identifier Source: org_study_id