NCT03825328

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2 pancreatic-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 30, 2019

Last Update Submit

January 30, 2019

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Chemotherapy

EXPERIMENTAL

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

Drug: Albumin-bound paclitaxelDrug: S-1Drug: OxaliplatinDrug: Gemcitabine

Interventions

Albumin-bound paclitaxelDRUG

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

Chemotherapy
S-1DRUG

a combination preparation of tegafur, gimeracil, and oteracil potassium

Chemotherapy
OxaliplatinDRUG

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.

Chemotherapy
GemcitabineDRUG

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.

Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in the trial and sign the informed consent form
  • 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)

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound PaclitaxelS 1 (combination)OxaliplatinGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsCoordination ComplexesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Zhang Yanqiao, PHD

CONTACT

13845120210yanqiaozhang@126.com

Wang Guangyu, PHD

CONTACT

1824903896618249038966@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the hospital

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

January 30, 2019

Primary Completion

January 30, 2020

Study Completion

December 30, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01