Actively Recruiting
Dose Escalation and Expansion Study of S-1 with Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Adenocarcinoma
Led by Chang Gung Memorial Hospital · Updated on 2026-05-22
70
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates metastatic pancreatic adenocarcinoma, a form of advanced pancreatic cancer with a poor survival rate. Researchers aim to evaluate a combination treatment using S-1 along with nab-paclitaxel and gemcitabine, known as the GAS regimen. This Phase 1b study focuses on finding the best dose that patients can tolerate and assessing potential side effects and tumor response. The study involves escalating doses of the GAS regimen given in cycles every 14 days. Three dose levels will be tested, adjusting the amounts of gemcitabine and nab-paclitaxel while dosing S-1 based on body surface area. The trial includes dose escalation and expansion phases to establish the maximum tolerated dose and recommended dose for further studies. Participants will receive treatment in cycles and undergo regular tumor assessments through imaging to monitor cancer progression or side effects. Researchers will measure outcomes including dose-limiting toxicities, tumor response rates, safety profiles, survival times, and disease control over up to three years. Patients will be closely monitored throughout the study to evaluate treatment effects and safety.
CONDITIONS
Brief Title
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic adenocarcinoma without neuroendocrine or squamous features
- Treatment-naïve stage IV disease with measurable tumors
- Measurable disease with at least one lesion 10 mm or larger on CT or MRI
- ECOG performance status of 0 or 1
- Life expectancy over 6 months as judged by physician
- At least 18 years old
- Ability to understand and comply with study procedures and provide informed consent
- Fertile patients agree to use contraception during study participation
- Adequate bone marrow function with specified blood count levels
- Adequate liver function within defined laboratory limits
- Adequate kidney function with creatinine clearance of at least 50 mL/min
- Able to take oral study medication (S-1)
- No clinically significant abnormal ECG within 28 days prior to enrollment
You will not qualify if you...
- Known endocrine pancreatic tumors or ampullary cancer
- Previous first line treatment for metastatic pancreatic cancer
- Serious active infections or major health conditions compromising study participation
- History of HIV or hepatitis B/C infection unless well-controlled
- Known brain cancer or metastases
- Concurrent blood cancers such as leukemia
- Other progressing cancers requiring treatment within last 6 months except certain skin or in situ cancers
- Positive pregnancy test or breastfeeding women
- Participation in other clinical trials within 30 days
- Inability to swallow capsules or significant gastrointestinal diseases
- Peripheral sensory neuropathy grade 2 or higher
- Any social or medical condition that may affect safety or compliance according to physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression or unacceptable side effects
Participants receive the GAS regimen consisting of gemcitabine, nab-paclitaxel, and S-1 in escalating doses as part of the dose escalation and expansion study for metastatic pancreatic adenocarcinoma.
Visits every 14 days for treatment administration and assessments
Duration - Up to 3 years after treatment ends
Participants are monitored for safety and treatment effects after stopping the GAS regimen.
Regular visits as scheduled for tumor assessments and safety monitoring
Trial Site Locations
Total: 3 locations
1
Chiayi Chung Gung Memmorial Hospital
Chiayi City, Taiwan, 613
Actively Recruiting
2
Chang-Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
Not Yet Recruiting
3
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan
Actively Recruiting
Research Team
W
Wen-Kuan Huang, MD, PhD
H
Hao-Yun Hsiao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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