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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03825328
• Other study ID #: HZ-NS/GEMOX-PC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 30, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2019
• Source: Harbin Medical University
• Contact: Zhang Yanqiao, PHD
• Phone: 13845120210
• Email: yanqiaozhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yanqiao Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	from the first drug administration up to 6 months
Primary	OS	overall survival	from the first drug administration up to 1 year