Metastatic Pancreatic AdenocarcinomaPhase 1GASNCT06229496
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
A Phase 1 study testing Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA), Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) and Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) in people with Metastatic Pancreatic Adenocarcinoma, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
Trial summary
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA), Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) and Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Aug 2023to 31 Dec 2028
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed pancreatic adenocarcinoma (poorly differentiated carcinoma is allowed in the absence of neuroendocrine features or squamous differentiation)
- Treatment-naï ve stage IV disease (measurable disease is required). Prior adjuvant chemotherapy or radiochemotherapy is allowed, if completed ≥ 6 months before enrollment.
- Measurable disease defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Life expectancy > 6 months in the opinion of his/her treating physician.
- At least 18 years of age
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- Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and sign the IRB-approved written informed consent
- Fertile female and male patients with child-bearing potential agree to use adequate contraceptive measures prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 X ULN (≤3.5 mg/dL if with adequate biliary tract drainage/stent placement) AST ≤ 3.0 X ULN (≤5.0X ULN if liver metastases are present) ALT ≤ 3.0 X ULN (≤5.0X ULN if liver metastases are present)
- Adequate renal function (defined as serum creatinine ≤ 1.5 X ULN or creatinine clearance rate (CCr) ≥ 50 mL/min (calculated by Cockroft-Gault formula; male: [(140 - age in years) × weight in kg)]/[72 × serum creatinine(mg/dL)];female=male x 0.85 )
- Able to take the oral study medication (S-1)
- No clinically significant abnormal ECG findings within 28 days (4 weeks) prior to enrollment
Who cannot join
- Have known endocrine pancreatic tumors or ampullary cancer
- Have received first line treatment for metastatic pancreatic cancer
- Have a serious concomitant active infection or other major comorbidities that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol (e.g., stroke, uncontrolled arrhythmia, heart failure, or active autoimmune disease)
- Have HIV history or hepatitis B and C infection, except for prescribing anti-hepatitis B medications for hepatitis B carrier and undetectable HCV RNA level for hepatitis C prior to enrollment.
- Have known central nervous system (CNS) malignancy or metastasis (screening is not required)
- Have concurrent hematologic malignancies, acute or chronic leukemia
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- Have known additional malignancy that is progressing or required active treatments within the past 6 months, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast or cervical cancer)
- Women with a positive pregnancy test or who are breastfeeding
- Have participated within the last 30 days in a clinical trial involving an investigational product
- Unable to swallow capsules or has diseases significantly affecting gastrointestinal function or resection of the stomach or small bowel, malabsorption syndrome, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- Current peripheral sensory neuropathy ≥ Grade 2
- Any social condition or diseases judged ineligible by physician for participation in the study due to safety concern
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Chiayi Chung Gung Memmorial Hospital
Chiayi City, 613
Chang-Hsien Lu, MD, 886975353096, q12014@cgmh.org.tw
- Not yet recruiting
Chang-Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City
Wen-Kuan Huang, MD, PhD, 033281200 ext. 2517, medfox0924@cgmh.org.tw
Hao-Yun Hsiao, MD, 033281200 ext. 5167, hyhsiao@cgmh.org.tw
- Recruiting
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan
Wen-Kuan Huang, MD,PhD, 033281200 ext. 2517, medfox0924@cgmh.org.tw
Hao-Yun Hsiao, MD, 033281200 ext. 5165, hyhsiao@cgmh.org.tw
About this study
Official title: A Phase 1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of S-1 in Combination With Nab-paclitaxel and Gemcitabine (GAS) in Subjects With Metastatic Pancreatic Adenocarcinoma
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. This study is a dose escalation and dose expansion study with the objective to establish the MTD and/or RP2D and/or DLT of nab-paclitaxel and gemcitabine in combination with a body surface area(BSA)-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) is the seventh leading cause of cancer- related death worldwide as the second leading cause of cancer mortality in the United States by 2030 . The overall 5-year survival rate is around 5% for advanced PDAC and 15-30% for resected PDAC. While recent advances have emerged in precision medicine and immunotherapy in a variety of cancer types, unfortunately these drugs are not applicable to most patients with PDAC. To date, polychemotherapy combinations remain the mainstay of systemic treatments for advanced PDAC. Of note, FOLFIRINOX is a triplet combination regimen while nab-Paclitaxel and gemcitabine is a doublet combination. Both NALIRIFOX and FOLFIRINOX showed the same median OS with about 11.1 months from NAPOLI 3 and PRODIGE4 trials, respectively, demonstrating the biologically comparable anti-tumor effects. On the other hand, the median OS of 8.5 months of gemcitabine plus nab-paclitaxel raised the question-would it be possible to add the third active drug in this doublet combination to achieve more potential efficacy, being comparable with triplet combination such as FOLFIRINOX or NALIRIFOX. Therefore, in this study the investigator aimed to investigate whether adding S-1 to nab-paclitaxel and gemcitabine as GAS regimen can be a potential triplet combination.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA), Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA), Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)
- Keywords
- Dose escalation, Pancreatic adenocarcinoma, GAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA)Combination product
Dose escalation study-dose level 1
Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)Combination product
Dose escalation study-dose level 2
Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)Combination product
Dose escalation study-dose level 3
| Study group | Role | What they receive |
|---|---|---|
| GAS regimen-dose level 1 | Experimental | Not described Receives: Combination Product: Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA) |
| GAS regimen-dose level 2 | Experimental | Not described Receives: Combination Product: Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) |
| GAS regimen-dose level 3 | Experimental | Not described Receives: Combination Product: Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
To determine a recommended Phase 2 dose (RP2D) of nab-paclitaxel and gemcitabine in combination with body surface area (BSA) - based dose of S-1 in subject with metastatic pancreatic adenocarcinoma
Measured: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Dose-limiting toxicity (DLT)
Measured: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Secondary outcomes (5)
Safety profile of GAS regimen
Safety profile will be recorded and graded according to NCI-CTCAE v 5.0.
Measured: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Disease Control Rate (DCR)
Defined as having complete response, partial response or stable disease at 12 weeks. (based on RECIST Version 1.1)
Measured: Through study completion, an average of 3 year
Duration of Response (DoR)
Time from documentation of tumor response to disease progression. (based on RECIST Version 1.1)
Measured: Through study completion, an average of 3 year
Progression-free Survival (PFS)
From the start date of study treatment to the date of progression disease or death. (based on RECIST Version 1.1)
Measured: Through study completion, an average of 3 year
Overall Survival (OS)
From the start date of study treatment to the date of death.
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh Chun-Nan, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229496
- Sponsor's protocol ID
- 202300649A3
- Acronym
- GAS
- Status last verified
- May 2026
- First submitted
- 9 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of S-1 in Combination With Nab-paclitaxel and Gemcitabine (GAS) in Subjects With Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06229496
- Acronym / sponsor ID
- GAS / 202300649A3
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- Dose escalation, Pancreatic adenocarcinoma, GAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jan 2024 (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.
A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. This study is a dose escalation and dose expansion study with the objective to establish the MTD and/or RP2D and/or DLT of nab-paclitaxel and gemcitabine in combination with a body surface area(BSA)-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) is the seventh leading cause of cancer- related death worldwide as the second leading cause of cancer mortality in the United States by 2030 . The overall 5-year survival rate is around 5% for advanced PDAC and 15-30% for resected PDAC. While recent advances have emerged in precision medicine and immunotherapy in a variety of cancer types, unfortunately these drugs are not applicable to most patients with PDAC. To date, polychemotherapy combinations remain the mainstay of systemic treatments for advanced PDAC. Of note, FOLFIRINOX is a triplet combination regimen while nab-Paclitaxel and gemcitabine is a doublet combination. Both NALIRIFOX and FOLFIRINOX showed the same median OS with about 11.1 months from NAPOLI 3 and PRODIGE4 trials, respectively, demonstrating the biologically comparable anti-tumor effects. On the other hand, the median OS of 8.5 months of gemcitabine plus nab-paclitaxel raised the question-would it be possible to add the third active drug in this doublet combination to achieve more potential efficacy, being comparable with triplet combination such as FOLFIRINOX or NALIRIFOX. Therefore, in this study the investigator aimed to investigate whether adding S-1 to nab-paclitaxel and gemcitabine as GAS regimen can be a potential triplet combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GAS regimen-dose level 1 | Experimental | Combination Product: Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA) |
| GAS regimen-dose level 2 | Experimental | Combination Product: Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) |
| GAS regimen-dose level 3 | Experimental | Combination Product: Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed pancreatic adenocarcinoma (poorly differentiated carcinoma is allowed in the absence of neuroendocrine features or squamous differentiation)
- Treatment-naï ve stage IV disease (measurable disease is required). Prior adjuvant chemotherapy or radiochemotherapy is allowed, if completed ≥ 6 months before enrollment.
- Measurable disease defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- Life expectancy > 6 months in the opinion of his/her treating physician.
Key exclusion criteria (12 listed)
- Have known endocrine pancreatic tumors or ampullary cancer
- Have received first line treatment for metastatic pancreatic cancer
- Have a serious concomitant active infection or other major comorbidities that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol (e.g., stroke, uncontrolled arrhythmia, heart failure, or active autoimmune disease)
- Have HIV history or hepatitis B and C infection, except for prescribing anti-hepatitis B medications for hepatitis B carrier and undetectable HCV RNA level for hepatitis C prior to enrollment.
- Have known central nervous system (CNS) malignancy or metastasis (screening is not required)
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 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA)Dose escalation study-dose level 1 | Combination product | GAS regimen-dose level 1 |
| Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)Dose escalation study-dose level 2 | Combination product | GAS regimen-dose level 2 |
| Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)Dose escalation study-dose level 3 | Combination product | GAS regimen-dose level 3 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
To determine a recommended Phase 2 dose (RP2D) of nab-paclitaxel and gemcitabine in combination with body surface area (BSA) - based dose of S-1 in subject with metastatic pancreatic adenocarcinoma
Dose-limiting toxicity (DLT)
Time frame: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Objective response rate (ORR)
Time frame: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
5 secondary outcomes
Safety profile of GAS regimen
Time frame: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 3 years
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 3 year
Duration of Response (DoR)
Time frame: Through study completion, an average of 3 year
Progression-free Survival (PFS)
Time frame: Through study completion, an average of 3 year
Overall Survival (OS)
Time frame: Through study completion, an average of 3 year
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 22 May 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA), Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) and Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA) in people with Metastatic Pancreatic Adenocarcinoma, run by Chang Gung Memorial Hospital at 3 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 15 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Wen-Kuan Huang, MD, PhD (03-3281200 ext. 2517, medfox0924@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: From cycle 1 day 1 (each cycle is 14 days) untill the date of radiographic tumor assessment confirm tumor recurrence or specified AE occur, assessed up to 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?
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 22 May 2026.