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

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Albumin-bound paclitaxel
DRUG: S-1
DRUG: Oxaliplatin
DRUG: Gemcitabine

HZ-NS/GEMOX-PC

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-30
First Submitted that Met QC Criteria 2019-01-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-31
First Posted (ACTUAL) 2019-01-31	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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	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 grou 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.

Participant Group/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 grou

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	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

Secondary Outcome Measures	Measure Description	Time Frame

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

Study Contact Backup

Name: Wang Guangyu, PHD

Phone Number: 18249038966

Email: 18249038966@163.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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

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Clinical Trial Record