Clinical trial · Interventional
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
NCT05026905CI-TRIAL-00116678active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Phase II, Open-label, Parallel 2-arm, Multi-center | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine 1000 mg | Drug | Gemcitabine | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- GASL arm
- description
- 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
- interventionNames
- Drug: Gemcitabine 1000 mg
- Drug: Nab paclitaxel
- Drug: S1
- Drug: leucovorin
- type
- OTHER
- label
- GAP arm
- description
- 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.
- interventionNames
- Drug: Gemcitabine 1000 mg
- Drug: Nab paclitaxel
- Drug: Oxaliplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.