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

• Sponsor: Yanqiao Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03825328
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 23

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Albumin-bound paclitaxel; Drug: S-1; Drug: Oxaliplatin; Drug: Gemcitabine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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
• Anticipated Study Start Date: Jan 30, 2019
• Anticipated Primary Completion Date: Jan 30, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PFS [from the first drug administration up to 6 months]

   progression-free survival

2. OS [from the first drug administration up to 1 year]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yanqiao Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanqiao Zhang, Director of the hospital, Harbin Medical University
• ClinicalTrials.gov Identifier: NCT03825328
• Other Study ID Numbers: HZ-NS/GEMOX-PC
• First Posted: Jan 31, 2019
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 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; Gemcitabine; Paclitaxel; Oxaliplatin; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Jan 31, 2019