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Cancer of PancreasPhase 2NCT03278015

Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

A Phase 2 study testing Nab-paclitaxel plus Gemcitabine, Gemcitabine monotherapy and S-1 monotherapy in people with Cancer of Pancreas, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer of Pancreas
What is being tested?
Nab-paclitaxel plus Gemcitabine, Gemcitabine monotherapy and S-1 monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Oct 2017to 30 Sep 2018
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed-consent form.
  • Man or woman aged 18 years to 80 years.
  • Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.
  • Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.
  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.
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  • Albumin ≥ 30 g/L.
  • Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN.
  • Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
  • Willing and able to comply with study procedures for the duration of the study.

Who cannot join

  • Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.
  • Patients have active cardiac disease including any of the following:
  • In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs.
  • Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.
  • Any factors may increase the risk of QTc prolongation or arrhythmic event.
  • Left ventricular ejection fraction (LVEF) < 50%.
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  • Patient weight still in losing period.
  • History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal occult blood test>= (+ +) within the past 6 months, shall not enter the trial. If fecal occult blood test (+), the patient is requested for gastroscopy.
  • Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.
  • Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant therapy.
  • Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, for example, HBV, HCV, or HIV.
  • Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
  • Patients with mental illness, or with psychiatric history of drug abuse.

Trial locations and contacts

1 site in 1 country.

Dabin Xu, M.D. contact

8613522065659

xdabin@126.com

China1 site

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.

Being tested
Nab-paclitaxel plus Gemcitabine, Gemcitabine monotherapy, S-1 monotherapy
Keywords
S-1, nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxel plus GemcitabineDrug

    Also called nab-paclitaxel abraxane ABI-007, GEMXAR

    Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

  • Gemcitabine monotherapyDrug

    Also called GEMXAR

    Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

  • S-1 monotherapyDrug

    S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Study groups in NCT03278015
Study groupRoleWhat they receive
Nab-paclitaxel plus GemcitabineExperimentalNanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Receives: Drug: Nab-paclitaxel plus Gemcitabine
Gemcitabine monotherapyExperimentalGemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Receives: Drug: Gemcitabine monotherapy
S-1 monotherapyExperimentalS-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
Receives: Drug: S-1 monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival(DFS)

    To determine the DFS of post-operative patients with pancreatic cancer

    Measured: 3 years

  2. overall survival time (OS)

    To determine the OS post-operative patients with pancreatic cancer

    Measured: 5 years

  3. median overall survival time (mOS)

    To determine the mOS post-operative patients with pancreatic cancer

    Measured: 5 years

Secondary outcomes (4)

  1. Objective Response Rate(ORR)

    All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

    Measured: 3 years

  2. Quality of Life Assessment

    Measured: 3 years

  3. safety profile

    Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups

    Measured: 3 years

  4. Disease control rate(DCR)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start1 Oct 2017 (estimated)
  3. Primary completion31 Mar 2018 (estimated)
  4. Study completion30 Sep 2018 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278015
Sponsor's protocol ID
XDB-001
Status last verified
Sep 2017
First submitted
8 Sep 2017
Last updated
11 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel plus Gemcitabine, Gemcitabine monotherapy and S-1 monotherapy in people with Cancer of Pancreas, run by Chinese PLA General Hospital at 1 site in China.

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 10 inclusion and 13 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Dabin Xu, M.D. (8613522065659, xdabin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival(DFS) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03278015.

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 11 Sep 2017.

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