- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825328
A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
January 30, 2019 updated by: Yanqiao Zhang
A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhang Yanqiao, PHD
- Phone Number: 13845120210
- Email: yanqiaozhang@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
|
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
a combination preparation of tegafur, gimeracil, and oteracil potassium
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: from the first drug administration up to 6 months
|
progression-free survival
|
from the first drug administration up to 6 months
|
OS
Time Frame: from the first drug administration up to 1 year
|
overall survival
|
from the first drug administration up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 30, 2019
Primary Completion (ANTICIPATED)
January 30, 2020
Study Completion (ANTICIPATED)
December 30, 2020
Study Registration Dates
First Submitted
January 30, 2019
First Submitted That Met QC Criteria
January 30, 2019
First Posted (ACTUAL)
January 31, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Oxaliplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- HZ-NS/GEMOX-PC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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