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Pancreatic CancerPhase 2ASAGPACNCT03636308

Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

A Phase 2 study testing nanoparticle albumin-bound paclitaxel, S1 and Gemcitabine in people with Pancreatic Cancer, run by Peking University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
nanoparticle albumin-bound paclitaxel, S1 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
17 Jul 2018to 1 Aug 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed-consent form.
  • Age no less than 18 years.
  • Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
  • Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
  • Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  • At least 4 weeks since completion of the last operation except for diagnostic biopsy.
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  • At least 4 weeks since completion of radiotherapy to lesions.
  • Not suitable for local treatment.
  • Adequate liver/bone marrow function.
  • Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
  • Compliant, and can be followed up regularly.

Who cannot join

  • Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  • Pregnant or breast-feeding female, or not willing to take contraception measures during study.
  • Serious infection requiring antibiotics intervention during recruitment.
  • Allergic to study drug.
  • More than grade 1 neuropathy.
  • Uncontrolled brain metastasis or mental illness.
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  • Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
  • Other malignancy within 5 years.
  • Can't be followed up or obey protocol.
  • Ineligible by the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

Jun Zhou contact

861088196561

13366152815@126.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital and Institute

    Beijing, Beijing Municipality, 100142

    Jun Zhou, MD

    Recruiting

Other trials in China

About this study

Official title: Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Read the detailed description

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Being tested
nanoparticle albumin-bound paclitaxel, S1, Gemcitabine
Keywords
advanced pancreatic cancer, nanoparticle albumin-bound paclitaxel, S-1, 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.

  • nanoparticle albumin-bound paclitaxelDrug

    Also called nab-paclitaxel, Abraxane, ABI-007

    Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.

  • S1Drug

    S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

  • GemcitabineDrug

    Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.

Study groups in NCT03636308
Study groupRoleWhat they receive
AS：Nanoparticle albumin-bound paclitaxel，S-1ExperimentalNanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle. S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
Receives: Drug: nanoparticle albumin-bound paclitaxel; Drug: S1
AG：Nanoparticle albumin-bound paclitaxel，GemcitabineActive comparatorNanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
Receives: Drug: nanoparticle albumin-bound paclitaxel; Drug: Gemcitabine

What is being measured

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

  1. Objective response rate

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes (5)

  1. Objective response rate of primary tumor

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. Progression-free survival

    Measure of time from study treatment to disease progression or death.

    Measured: up to 15 months

  3. Overall survival

    Measure of time from study treatment to patient's death or lost to follow-up.

    Measured: up to 2 years

  4. Disease control rate

    The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  5. The incidence of treatment related emergent adverse events（Safety and Tolerance）

    Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version

    Measured: Until 28 days after the deadline of enrollment

Timeline

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

  1. First posted17 Aug 2018
  2. Study start17 Jul 2018
  3. Primary completion1 Aug 2020 (estimated)
  4. Study completion1 Aug 2021 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03636308
Sponsor's protocol ID
ASAG01
Acronym
ASAGPAC
Status last verified
Aug 2018
First submitted
1 Aug 2018
Last updated
17 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jin M, Liu HL, Xue J, Ma H, Liu JL, Lin ZY, Wang J, Bao LQ, Luo ZG, Yu XJ, Li S, Hu JL, Zhang T. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study. Oncologist. 2024 Oct 3;29(10):e1406-e1418. doi: 10.1093/oncolo/oyae171.

    PubMed 38990195

  • Zong Y, Yuan J, Peng Z, Lu M, Wang X, Shen L, Zhou J. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. J Cancer Res Clin Oncol. 2021 May;147(5):1529-1536. doi: 10.1007/s00432-020-03442-0. Epub 2020 Nov 15.

    PubMed 33191450

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nanoparticle albumin-bound paclitaxel, S1 and Gemcitabine in people with Pancreatic Cancer, run by Peking University 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 11 inclusion and 10 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 17 Aug 2018. 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 Jun Zhou (861088196561, 13366152815@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT03636308, which also lists 2 linked publications.

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 17 Aug 2018.

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