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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Albumin-bound paclitaxel

S-1

Oxaliplatin

Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles

Outcomes

Primary Outcome Measures

PFS

progression-free survival

overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03825328

First Posted

January 30, 2019

Last Updated

January 30, 2019

Sponsor

Yanqiao Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03825328

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 30, 2019 (Anticipated)

Primary Completion Date

January 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yanqiao Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy

Arm Type

Experimental

Arm Description

Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles

Intervention Type

Drug

Intervention Name(s)

Albumin-bound paclitaxel

Intervention Description

Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.

Intervention Type

Drug

Intervention Name(s)

S-1

Intervention Description

a combination preparation of tegafur, gimeracil, and oteracil potassium

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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 Measure Information:

Title

PFS

Description

progression-free survival

Time Frame

from the first drug administration up to 6 months

Title

Description

overall survival

Time Frame

from the first drug administration up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Yanqiao, PHD

Phone

13845120210

yanqiaozhang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wang Guangyu, PHD

Phone

18249038966

18249038966@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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