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

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ClinicalTrials.gov Identifier: NCT03825328
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Yanqiao Zhang, Harbin Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Albumin-bound paclitaxel Drug: S-1 Drug: Oxaliplatin Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
Drug: Albumin-bound paclitaxel
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.

Drug: S-1
a combination preparation of tegafur, gimeracil, and oteracil potassium

Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. PFS [ Time Frame: from the first drug administration up to 6 months ]
    progression-free survival

  2. OS [ Time Frame: from the first drug administration up to 1 year ]
    overall survival



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily participate in the trial and sign the informed consent form
  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:

  1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
  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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825328


Contacts
Contact: Zhang Yanqiao, PHD 13845120210 yanqiaozhang@126.com
Contact: Wang Guangyu, PHD 18249038966 18249038966@163.com

Sponsors and Collaborators
Yanqiao Zhang

Responsible Party: Yanqiao Zhang, Director of the hospital, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03825328     History of Changes
Other Study ID Numbers: HZ-NS/GEMOX-PC
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Oxaliplatin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs