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
NCT ID: NCT05026905
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2021-12-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GASL arm
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
Gemcitabine 1000 mg
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 paclitaxel
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
S1
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
leucovorin
leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
GAP arm
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.
Gemcitabine 1000 mg
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 paclitaxel
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
Oxaliplatin
Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
Interventions
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Gemcitabine 1000 mg
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 paclitaxel
Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
S1
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
leucovorin
leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
Oxaliplatin
Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Taichung Veterans General Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Li-Tzong Chen, MD, Ph.D.
Role: STUDY_CHAIR
National Health Research Institutes, Taiwan
Yung-Yeh Su, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Health Research Institutes, Taiwan
Shang-Hung Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Health Research Institutes, Taiwan
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Countries
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Other Identifiers
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T5221
Identifier Type: -
Identifier Source: org_study_id
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