Phase II, Open-label, Parallel 2-arm, Multi-centerPhase 2NCT05026905
A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine 1000 mg, Nab paclitaxel and S1 in people with Phase II, Open-label, Parallel 2-arm, Multi-center, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial summary
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Phase II, Open-label, Parallel 2-arm, Multi-center
- What is being tested?
- Gemcitabine 1000 mg, Nab paclitaxel and S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesTaiwan
- Study dates
- 28 Dec 2021to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.
- B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study.
- C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated.
- D.At least one measurable lesion according to RECIST version 1.1
- E.Ability to understand and willingness to sign a written informed consent document.
- F.ECOG performance status 0-1
Show all 10Show fewer
- G.Age of 20 years or above
- H.Adequate organ function as defined by the following criteria:
- absolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥ 100,000/mm3 total bilirubin ≤ 2 ULN or ≤5 ULN if caused by biliary obstruction and achieving adequate drainage judged by investigator aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0×ULN in the presence of liver metastases creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: [(140 - age) × weight (kg)]/[72 × serum creatinine(mg/dL)];female=male x 0.85
- -I.Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
Who cannot join
- A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.
- B.Active or uncontrolled infection;
- C.Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion
- D.Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
- E.History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 800
China Medical University Hospital
Taichung, 400
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan, 600
About this study
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. This study will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
Read the detailed description
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. However, the nephrotoxicity of cisplatin is always a concern therefore cisplatin was substituted with oxaliplatin in current study. S-1 monotherapy has shown promising anti-tumor activity against PDAC with a manageable safety profile which provided the opportunity of combination with other agents. In this study, we will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
- Being tested
- Gemcitabine 1000 mg, Nab paclitaxel, S1, leucovorin, Oxaliplatin
- Keywords
- Metastatic Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine 1000 mgDrug
Also called Gemcitabine
Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.
Nab paclitaxelDrug
Also called nab-paclitaxel
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
S1Drug
Also called S-1
S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
- BSA < 1.25 m2: 60 mg/day
- 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day
- BSA ≥ 1.5 m2: 100 mg/day
leucovorinDrug
Also called Calcium Folinate tablet
leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
OxaliplatinDrug
Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
| Study group | Role | What they receive |
|---|---|---|
| GASL arm | Other | eligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day [depending on patient's baseline body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
* BSA < 1.25 m2: 60 mg/day
* 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day
* BSA ≥ 1.5 m2: 100 mg/day Receives: Drug: Gemcitabine 1000 mg; Drug: Nab paclitaxel; Drug: S1; Drug: leucovorin |
| GAP arm | Other | eligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle. Receives: Drug: Gemcitabine 1000 mg; Drug: Nab paclitaxel; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best objective response rate (ORR)
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: 6 years
Secondary outcomes (5)
Disease control rate (DCR)
Defined as having complete response, partial response or stable disease at least 12 weeks.
Measured: 6 years
Progression-free survival (PFS)
from the start date of study treatment to the date of progression disease or death.
Measured: 6 years
Overall survival (OS)
from the start date of study treatment to the date of death.
Measured: 6 years
Duration of response (DOR)
time from documentation of tumor response to disease progression.
Measured: 6 years
Incidence of Treatment-related Adverse Events [Safety and Tolerability]
This study will utilize the NCI-CTCAE v5.0 for Adverse Event monitoring and reporting
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start28 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase II, Open-label, Parallel 2-arm, Multi-centerStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taichung Veterans General Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, MD, Ph.D., Study chair, National Health Research Institutes, TaiwanYung-Yeh Su, M.D., Principal investigator, National Health Research Institutes, TaiwanShang-Hung Chen, M.D., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026905
- Sponsor's protocol ID
- T5221
- Status last verified
- Jun 2026
- First submitted
- 24 Aug 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05026905
- Acronym / sponsor ID
- T5221
- Keywords
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taichung Veterans General Hospital
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Aug 2021 (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.
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. This study will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
Detailed description
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. However, the nephrotoxicity of cisplatin is always a concern therefore cisplatin was substituted with oxaliplatin in current study. S-1 monotherapy has shown promising anti-tumor activity against PDAC with a manageable safety profile which provided the opportunity of combination with other agents. In this study, we will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GASL arm | Other | Drug: Gemcitabine 1000 mg, Drug: Nab paclitaxel, Drug: S1, Drug: leucovorineligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day [depending on patient's baseline body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA < 1.25 m2: 60 mg/day * 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day * BSA ≥ 1.5 m2: 100 mg/day |
| GAP arm | Other | Drug: Gemcitabine 1000 mg, Drug: Nab paclitaxel, Drug: Oxaliplatineligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.
- B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study.
- C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated.
- D.At least one measurable lesion according to RECIST version 1.1
- E.Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (5 listed)
- A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.
- B.Active or uncontrolled infection;
- C.Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion
- D.Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
- E.History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.
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 |
|---|---|---|
| Gemcitabine 1000 mgAlso: GemcitabineGemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days. | Drug | GAP arm, GASL arm |
| Nab paclitaxelAlso: nab-paclitaxelNab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine | Drug | GAP arm, GASL arm |
| S1Also: S-1S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA < 1.25 m2: 60 mg/day * 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day * BSA ≥ 1.5 m2: 100 mg/day | Drug | GASL arm |
| leucovorinAlso: Calcium Folinate tabletleucovorin 30mg BID day 1 to 7 on in a 2-week cycle | Drug | GASL arm |
| OxaliplatinOxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days | Drug | GAP arm |
Primary outcome
Best objective response rate (ORR)
Time frame: 6 years
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
5 secondary outcomes
Disease control rate (DCR)
Time frame: 6 years
Progression-free survival (PFS)
Time frame: 6 years
Overall survival (OS)
Time frame: 6 years
Duration of response (DOR)
Time frame: 6 years
Incidence of Treatment-related Adverse Events [Safety and Tolerability]
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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.
Li-Tzong Chen, MD, Ph.D. study chair
National Health Research Institutes, Taiwan
Yung-Yeh Su, M.D. principal investigator
National Health Research Institutes, Taiwan
Shang-Hung Chen, M.D. principal investigator
National Health Research Institutes, Taiwan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine 1000 mg, Nab paclitaxel and S1 in people with Phase II, Open-label, Parallel 2-arm, Multi-center, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best objective response rate (ORR) (time frame: 6 years). 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 2 Jul 2026.