Pancreatic CancerPhase 2NCT03825328
A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
A Phase 2 study testing Albumin-bound paclitaxel, S-1 and Oxaliplatin in people with Pancreatic Cancer, run by Yanqiao Zhang.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Albumin-bound paclitaxel, S-1 and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2019to 30 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Albumin-bound paclitaxel, S-1, Oxaliplatin, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound paclitaxelDrug
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
S-1Drug
a combination preparation of tegafur, gimeracil, and oteracil potassium
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles Receives: Drug: Albumin-bound paclitaxel; Drug: S-1; Drug: Oxaliplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: from the first drug administration up to 6 months
OS
overall survival
Measured: from the first drug administration up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start30 Jan 2019 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqiao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqiao Zhang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825328
- Sponsor's protocol ID
- HZ-NS/GEMOX-PC
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03825328
- Acronym / sponsor ID
- HZ-NS/GEMOX-PC
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yanqiao ZhangUniversity, hospital or other
- Study start
- 30 Jan 2019 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Albumin-bound paclitaxel, Drug: S-1, Drug: Oxaliplatin, Drug: GemcitabineAlbumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin-bound paclitaxelAlbumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. | Drug | Chemotherapy |
| S-1a combination preparation of tegafur, gimeracil, and oteracil potassium | Drug | Chemotherapy |
| OxaliplatinThe 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 | Chemotherapy |
| GemcitabineGemcitabine 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. | Drug | Chemotherapy |
Primary outcome
PFS
Time frame: from the first drug administration up to 6 months
progression-free survival
OS
Time frame: from the first drug administration up to 1 year
overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin-bound paclitaxel, S-1 and Oxaliplatin in people with Pancreatic Cancer, run by Yanqiao Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yanqiao, PHD (13845120210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first drug administration up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.